Activity of pemetrexed in thoracic malignancies

Size: px
Start display at page:

Download "Activity of pemetrexed in thoracic malignancies"

Transcription

1 Activity of pemetrexed in thoracic malignancies Results of phase III clinical studies of pemetrexed in malignant pleural mesothelioma and non-small cell lung cancer show benefit P emetrexed (Alimta) is an antifolate agent with activity in many tumor types. Its mechanism of action involves inhibition of several enzymes involved in nucleotide synthesis principally thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyltransferase thereby inhibiting the replication of tumor cells. Initial experience with the agent showed that it produced rates of hematologic and non-hematologic toxicities similar to those of other antifolate compounds and antimetabolites. Subsequently, it was shown that these toxicities could be markedly reduced through routine folic acid and vitamin B 12 supplementation without adversely affecting the efficacy of the agent. 1 Pemetrexed has recently been evaluated in phase III trials in the settings of malignant pleural mesothelioma and non-small cell lung cancer (NSCLC). lowed 2 hours later by cisplatin (75 mg/m² via a 2-hour infusion) or cisplatin alone on day 1 every 21 days. Folic acid and vitamin B 12 supplementation was not instituted until after 117 patients had been enrolled. Thereafter, patients randomized to receive pemetrexed therapy received folic acid (350 1,000 µg orally) each day, beginning 1 3 weeks before the first dose of pemetrexed and continuing throughout the study therapy, and vitamin B 12 (1,000 µg intramuscularly) 1 3 weeks before starting treatment with pemetrexed and every 9 weeks during treatment. To prevent skin rash, patients treated with pemetrexed were also given dexamethasone on the day before, the day of, and the day after treatment. Patients in the cisplatin-alone group received a saline infusion, vitamin supplementation, and dexamethasone to maintain patient blinding. Baseline characteristics The pemetrexed/cisplatin and cisplatin-alone treatment groups were well matched with regard to baseline characteristics: Median age was Pemetrexed/cisplatin versus cisplatin alone in mesothelioma In the mesothelioma trial, 2 the combination of pemetrexed and cisplatin was compared with cisplatin alone in 456 patients with malignant pleural mesothelioma who were chemotherapy naïve and ineligible for curative surgery. Patients were randomized to receive pemetrexed (500 mg/m² via a 10-minute infusion) fol- Summary by Matt Stenger, MS; reviewed by Ben Solomon, MBBS, PhD, and Paul A. Bunn, Jr., MD, University of Colorado Cancer Center, Denver, CO. FIGURE 1 Kaplan-Meier estimates of overall survival among patients with malignant pleural mesothelioma treated with pemetrexed and cisplatin versus cisplatin alone. Reproduced from Vogelzang et al 2 with permission from the American Society of Clinical Oncology Elsevier Inc. All rights reserved. January/February 2005 COMMUNITY ONCOLOGY 21

2 Setting a new mesothelioma treatment standard Ben Solomon, MBBS, PhD, and Paul A. Bunn, Jr., MD University of Colorado Cancer Center, Denver NTIL RECENTLY, no proven systemic treatments existed for U patients with unresectable malignant pleural mesothelioma. The study by Vogelzang and colleagues described in this summary led in February 2004 to US Food and Drug Administration (FDA) approval of pemetrexed (Alimta) in combination with cisplatin for use in the treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery. This large, well-designed, randomized study represents the largest phase III study in mesothelioma reported to date. Patients randomized to the investigational pemetrexed/cisplatin treatment arm demonstrated a statistically significant improvement in clinical outcome, compared with those assigned to the cisplatin control arm, in terms of survival, time to disease progression, and response rate. Importantly, treatment with the pemetrexed/cisplatin combination was also found to result in improved pulmonary function and in improved patient-reported symptom scores and quality of life, compared with cisplatin-only treatment. Thus, this combination is the standard and only FDA-approved therapy for unresectable mesothelioma. Vitamin supplementation important The importance of folic acid and vitamin B 12 supplementation in patients treated with pemetrexed is highlighted in Vogelzang s study. Major toxicity, with three drug-related deaths, was seen in the first 43 patients (7%) recruited to the combination pemetrexed/cisplatin arm. Multivariate analyses of the outcomes of phase I and II studies in patients receiving pemetrexed demonstrated that deficiencies of folic acid and vitamin B 12 predicted an increased risk of various toxicities, including drugrelated death. 1 Elevated total plasma homocysteine (a marker of folic acid and also vitamin B 12 deficiency) levels were found to significantly predict severe thrombocytopenia, neutropenia, diarrhea, mucositis, and infection. Elevated methylmalonic levels (a specific marker of vitamin B 12 deficiency) predicted an increased risk of diarrhea and mucositis. These observations led to the recommendation that all patients treated with pemetrexed receive supplementation with a daily low oral dose of folic acid plus intramuscular injections of vitamin B 12 every 3 months. Folic acid and vitamin B 12 supplementation provided in this way not only reduces pemetrexed toxicity but also allows for the delivery of more cycles of pemetrexed chemotherapy and is associated with preserved or possibly increased efficacy. Reference 1. Niyikiza C, Hanauske AR, Rusthoven JJ, et al. Pemetrexed safety and dosing strategy. Semin Oncol 2002;29(suppl 18): Dr. Bunn is Grohne/ Stapp Professor and Director at the University of Colorado Cancer Center, Denver. Dr. Solomon is a fellow at the same institution. 61 years versus 60 years, respectively; 81.4% of the pemetrexed/cisplatin group were male versus 81.5% of the cisplatin-only group; 51.8% versus 56.3%, respectively, had a Karnofsky performance status of ; 68.1% versus 68.5% had an epithelial histology; and 7.1%, 15.6%, 32.4%, and 45.1% of patients receiving combination therapy versus 6.3%, 15.0%, 30.9%, and 48.2% of those receiving cisplatin alone had stage I, II, III, and IV disease, respectively. In all, 226 patients in the pemetrexed/cisplatin treatment group versus 222 in the cisplatin-alone group constituted the intent-to-treat population. Of this population, 168 versus 163 received full vitamin supplementation, 26 versus 21 received partial supplementation, and 32 versus 38 received no supplementation. Baseline characteristics among these subgroups were also similar. Efficacy Median survival was 12.1 months in the pemetrexed/cisplatin treatment group, significantly greater than the median survival of 9.3 months in the group that received cisplatin only (P = 0.020; Figure 1). The hazard ratio for death in the pemetrexed/cisplatin arm, compared with that in the cisplatin-only arm, was The difference in median survival did not quite reach significance among the patients receiving full vitamin supplementation (P = 0.051) but did so among all patients who received full or partial supplementation (P = 0.022). No difference between the subgroups who received no vitamin supplementation was observed, probably reflecting the small patient numbers in these two subgroups. Median time to disease progression was significantly longer (P < 0.01) in the pemetrexed/cisplatin treatment group among all patients, among those who received full vitamin supplementation, and among those with full or partial supplementation. The tumor response rate, assessed by se- 22 COMMUNITY ONCOLOGY January/February 2005

3 rial computed tomographic scanning, was significantly greater (P < 0.001) in the pemetrexed/cisplatin treatment group, that is the group receiving cisplatin only, among all patients, among patients who had full vitamin supplementation, and among those with full or partial supplementation. All responses to chemotherapy were partial responses. Safety Compared with cisplatin therapy alone, pemetrexed/cisplatin treatment was associated with a significantly higher incidence of grade 3 or 4 hematologic and non-hematologic toxicities among all patients, including significantly more grade 3 or 4 nausea, vomiting, diarrhea, dehydration, and stomatitis (Table 1). Vitamin supplementation, however, reduced the frequency of adverse events. Patients who received pemetrexed/cisplatin therapy with full vitamin supplementation had significantly fewer occurrences of neutropenia or neutropenia with infection, as well as other grade 3/4 toxicities, compared with similarly treated patients who had partial or no vitamin supplementation (Table 2). Patients with full or partial vitamin supplementation had significantly reduced frequencies of leukopenia, nausea, vomiting, and febrile neutropenia, compared with patients receiving no supplementation. Conclusion These findings indicate a clear superiority of pemetrexed/cisplatin therapy over cisplatin alone in terms of survival time, time to disease progression, and objective response rates in patients with malignant pleural mesothelioma, although there is some cost in terms of increased toxicity. The findings also indicate, however, that the addition of folic acid and vitamin B 12 to pemetrexed therapy can markedly reduce toxicity without adversely affecting its efficacy. TABLE 1 Incidence (%) of grade 3/4 toxicities observed in mesothelioma patients receiving pemetrexed/cisplatin versus cisplatin alone Pemetrexed/cisplatin Cisplatin alone Toxicity (n = 226) (n = 222) Neutropenia Febrile neutropenia Neutropenia with infection Leukopenia Anemia Thrombocytopenia Nausea Vomiting Fatigue Diarrhea Dehydration Stomatitis Anorexia Rash Adapted from Vogelzang et al 2 with permission from the American Society of Clinical Oncology. TABLE 2 Incidence (%) of grade 3/4 toxicities observed in mesothelioma patients receiving pemetrexed/cisplatin with full or no vitamin supplementation Full supplementation No supplementation Toxicity (n = 168) (n = 32) Neutropenia Febrile neutropenia Neutropenia with infection Leukopenia Anemia Thrombocytopenia Nausea Vomiting Fatigue Diarrhea Dehydration Stomatitis Anorexia Rash Adapted from Vogelzang et al 2 with permission from the American Society of Clinical Oncology. January/February 2005 COMMUNITY ONCOLOGY 23

4 Pemetrexed versus docetaxel as secondline therapy for NSCLC In the lung cancer trial, patients who had received one prior chemotherapy regimen for advanced NSCLC and who had adequate organ function and an ECOG performance status of 0 2 were randomized to receive pemetrexed (500 mg/m² via a 10-minute infusion) or docetaxel (Taxotere; 75 mg/m² via a 1-hour infusion) on day 1 every 21 days. Patients receiving pemetrexed were instructed to take folic acid (350 1,000 µg orally) each day, beginning 1 2 weeks before the first dose of pemetrexed and continuing until 3 weeks after the last dose; in addition, a 1,000-µg vitamin B 12 injection was given intramuscularly 1 2 weeks before pemetrexed therapy was started and approximately every 9 weeks thereafter until study discontinuation. Dexamethasone (4 mg twice daily in the pemetrexed treatment group and 8 mg twice daily in the docetaxel treatment group) was administered the day before, the day of, and the day after study drug treatment to prevent skin rash. Baseline characteristics Both patient groups were well matched with regard to baseline characteristics: 68.6% of patients randomized to receive pemetrexed therapy versus 75.3% of those assigned to treatment with docetaxel were male; median age was 59 years versus 57 years, respectively; 88.6% versus 87.6% had an ECOG performance status of 0 or 1; 54.4% versus 49.3% had adenocarcinoma; 27.6% versus 32.3% had squamous cell cancer; 25.8% versus 27.8% had previously been treated with paclitaxel; and 44.2% versus 45.5% had received prior radiation therapy. Efficacy Objective response rates were 9.1% in the pemetrexed treatment FIGURE 2 Kaplan-Meier estimates of overall survival of patients given docetaxel versus pemetrexed as second-line therapy for non-small cell lung cancer. Reproduced from Hanna et al 3 with permission from the American Society of Clinical Oncology. arm and 8.8% in the docetaxel therapy arm, with stable disease occurring in 45.8% versus 46.4% of patients in both arms, respectively. Median disease progression-free survival was 2.9 months in each arm. Median survival was 8.3 months in the pemetrexed treatment arm versus 7.9 months in the docetaxel treatment arm, and the 1-year survival rate was 29.7% in each arm (Figure 2). The treatment groups did not differ significantly in any of these efficacy variables; however, a borderline significant improvement in median time to treatment failure was observed in the pemetrexed treatment group (2.3 months vs 2.1 months in the docetaxel group, P = 0.046). Safety Major differences in toxicity were observed between the two treatment arms (Table 3). Significantly more common in the docetaxel therapy arm were grade 3 or 4 neutropenia (40.2% vs 5.3%), febrile neutropenia (12.7% vs 1.9%), neutropenia with infection (3.3% vs 0.0%), hospitalizations for febrile neutropenia (13.4% vs 1.5%), use of colony-stimulating factor support (19.2% vs 2.6%), and alopecia (37.7% vs 6.4%). A grade 3 or 4 increase in serum alanine aminotransferase levels were observed in 1.9% of patients receiving pemetrexed, compared with none of the patients who received docetaxel. Conclusion These findings indicate that pemetrexed treatment is associated with equivalent efficacy and fewer adverse effects, compared with docetaxel, as second-line treatment of advanced NSCLC and suggest that pemetrexed should be considered a standard option in this setting. 24 COMMUNITY ONCOLOGY January/February 2005

5 TABLE 3 Incidence (%) of grade 3/4 toxicities observed in patients receiving pemetrexed or docetaxel as second-line treatment of advanced NSCLC Pemetrexed Docetaxel Toxicity/resource utilization (n = 265) (n = 276) P value a Neutropenia < Febrile neutropenia < Neutropenia with infection Anemia Thrombocytopenia Hospitalizations and supportive care 1 Hospitalizations for < neutropenic fever Granulocyte or granulocyte < macrophage colony-stimulating factor support Erythropoietin support Red blood cell transfusion Alopecia b < Fatigue Nausea Elevation in serum ALT level a Fisher s exact test. b Any grade. ALT = alanine aminotranferase. Adapted from Hanna et al 3 with permission from the American Society of Clinical Oncology. References 1. Niyikiza C, Hanauske AR, Rusthoven JJ, et al. Pemetrexed safety and dosing strategy. Semin Oncol 2002;29(suppl 18): Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003;21: Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non smallcell lung cancer previously treated with chemotherapy. J Clin Oncol 2004;22: Pemetrexed: equivalent to docetaxel but less toxic Ben Solomon, MBBS, PhD, and Paul A. Bunn, Jr., MD University of Colorado Cancer Center, Denver HE PLACE OF DOCETAXEL (Taxotere) in the second-line treat- T ment of non-small cell lung cancer (NSCLC) has been firmly established by randomized studies in which docetaxel has been compared with best supportive care 1 or chemotherapy with vinorelbine or ifosfamide (Ifex). 2 The study of Hanna and colleagues described in this report utilized a non-inferiority statistical design to demonstrate the equivalence of pemetrexed (Alimta) with docetaxel in this setting. This multicenter study randomized 571 patients who had received one previous chemotherapy regimen to undergo treatment with either pemetrexed or docetaxel and represents the largest phase III study conducted to date in the second-line treatment of NSCLC. Treatment with pemetrexed resulted in efficacy equivalent to that of docetaxel, as measured by objective response rate, median disease progression-free survival, and median survival. Patientreported symptomatic improvement was largely equivalent in both treatment groups. However, treatment with pemetrexed, administered with concomitant folic acid and vitamin B 12 supplementation, was associated with less toxicity. Most significantly reduced rates of neutropenia and its related complications including febrile neutropenia and hospitalizations for neutropenic fever were seen in patients receiving pemetrexed. In addition, less alopecia was seen with pemetrexed than with docetaxel. This study establishes pemetrexed as a less-toxic alternative to docetaxel for the second-line treatment of patients with NSCLC and led to accelerated FDA approval of its use in this setting in July References 1. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol : Fossella FV, DeVore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non- Small Cell Lung Cancer Study Group. J Clin Oncol 2000;18: January/February 2005 COMMUNITY ONCOLOGY 25

Prior Authorization Guideline

Prior Authorization Guideline Prior Authorization Guideline Guideline: PS Inj - Alimta Therapeutic Class: Antineoplastic Agents Therapeutic Sub-Class: Antifolates Client: PS Inj Approval Date: 8/2/2004 Revision Date: 12/5/2006 I. BENEFIT

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium pemetrexed 500mg infusion (Alimta ) No. (192/05) Eli Lilly 8 July 2005 The Scottish Medicines Consortium has completed its assessment of the above product and advises NHS

More information

Third-line or fourth-line chemotherapy in non-small-cell lung cancer patients with relatively good performance status

Third-line or fourth-line chemotherapy in non-small-cell lung cancer patients with relatively good performance status Available online at www.sciencedirect.com Journal of the Chinese Medical Association 74 (2011) 209e214 Original Article Third-line or fourth-line chemotherapy in non-small-cell lung cancer patients with

More information

Medication Policy Manual. Topic: Alimta, pemetrexed Date of Origin: May 12, 2010

Medication Policy Manual. Topic: Alimta, pemetrexed Date of Origin: May 12, 2010 Medication Policy Manual Policy No: dru213 Topic: Alimta, pemetrexed Date of Origin: May 12, 2010 Committee Approval Date: February 17, 2015 Next Review Date: February 2016 Effective Date: March 1, 2015

More information

Advances In Chemotherapy For Hormone Refractory Prostate Cancer. TAX 327 study results & SWOG 99-16 study results presented at ASCO 2004

Advances In Chemotherapy For Hormone Refractory Prostate Cancer. TAX 327 study results & SWOG 99-16 study results presented at ASCO 2004 Ronald de Wit Rotterdam Cancer Institute The Netherlands Advances In Chemotherapy For Hormone Refractory Prostate Cancer TAX 327 study results & SWOG 99-16 study results presented at Slide 1 Prostate Cancer

More information

Maintenance therapy in in Metastatic NSCLC. Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai

Maintenance therapy in in Metastatic NSCLC. Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai Maintenance therapy in in Metastatic NSCLC Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai Definition of Maintenance therapy The U.S. National Cancer Institute s

More information

DECISION AND SUMMARY OF RATIONALE

DECISION AND SUMMARY OF RATIONALE DECISION AND SUMMARY OF RATIONALE Indication under consideration Clinical evidence Crizotinib as 2nd line treatment for patients with anaplastic lymphoma kinase (ALK) positive lung cancer Score The application

More information

Background. t 1/2 of 3.7 4.7 days allows once-daily dosing (1.5 mg) with consistent serum concentration 2,3 No interaction with CYP3A4 inhibitors 4

Background. t 1/2 of 3.7 4.7 days allows once-daily dosing (1.5 mg) with consistent serum concentration 2,3 No interaction with CYP3A4 inhibitors 4 Abstract No. 4501 Tivozanib versus sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma: Results from a Phase III randomized, open-label, multicenter trial R. Motzer, D.

More information

Summary of treatment benefits

Summary of treatment benefits Risk Management Plan PEMETREXED Powder for concentrate for Solution for infusion Pemetrexed is also indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non small cell

More information

Is the third-line chemotherapy feasible for non-small cell lung cancer? A retrospective study

Is the third-line chemotherapy feasible for non-small cell lung cancer? A retrospective study Turkish Journal of Cancer Volume 34, No.1, 2004 19 Is the third-line chemotherapy feasible for non-small cell lung cancer? A retrospective study MUSTAFA ÖZDO AN, MUSTAFA SAMUR, HAKAN BOZCUK, ERKAN ÇOBAN,

More information

REPORT ASCO 2002 ORLANDO : LUNG CANCER Johan F. Vansteenkiste, MD, PhD, Univ. Hospital and Leuven Lung Cancer Group

REPORT ASCO 2002 ORLANDO : LUNG CANCER Johan F. Vansteenkiste, MD, PhD, Univ. Hospital and Leuven Lung Cancer Group REPORT ASCO 2002 ORLANDO : LUNG CANCER Johan F. Vansteenkiste, MD, PhD, Univ. Hospital and Leuven Lung Cancer Group In the 2002 edition of the ASCO meeting, a total of 315 abstracts in the field of respiratory

More information

Pemetrexed in the treatment of thoracic malignancies: a single centre experience in Singapore

Pemetrexed in the treatment of thoracic malignancies: a single centre experience in Singapore Original Article Singapore Med J 2011; 52(3) : 190 Pemetrexed in the treatment of thoracic malignancies: a single centre experience in Singapore Lopes G, Chopra A, Kukutschka J, Portillo P, Bharwani L,

More information

POLICY A. INDICATIONS

POLICY A. INDICATIONS Alimta (pemetrexed) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 09/01/2007 Current Effective Date: 10/01/2015 POLICY A. INDICATIONS The indications below

More information

NCCN Non-Small Cell Lung Cancer V.1.2011 Update Meeting 07/09/10

NCCN Non-Small Cell Lung Cancer V.1.2011 Update Meeting 07/09/10 Guideline Page and Request NSCL-3 Stage IA, margins positive delete the recommendation for chemoradiation. Stage IB, IIA, margins positive delete the recommendation for chemoradiation + Stage IIA, Stage

More information

MALIGNANT PLEURAL mesothelioma (MPM) is a locally

MALIGNANT PLEURAL mesothelioma (MPM) is a locally Phase III Study of Pemetrexed in Combination With Versus Alone in Patients With Malignant Pleural Mesothelioma By Nicholas J. Vogelzang, James J. Rusthoven, James Symanowski, Claude Denham, E. Kaukel,

More information

Second-Line Treatment Options in Non Small Cell Lung Cancer: A Comparison of Cytotoxic Agents and Targeted Therapies

Second-Line Treatment Options in Non Small Cell Lung Cancer: A Comparison of Cytotoxic Agents and Targeted Therapies Second-Line Treatment Options in Non Small Cell Lung Cancer: A Comparison of Cytotoxic Agents and Targeted Therapies Filippo de Marinis, a Stefano De Santis, a and Luigi De Petris b Current options for

More information

West of Scotland Cancer Network Chemotherapy Protocol. Cisplatin and Pemetrexed for Malignant Mesothelioma (LUWOS 0021)

West of Scotland Cancer Network Chemotherapy Protocol. Cisplatin and Pemetrexed for Malignant Mesothelioma (LUWOS 0021) West of Scotland Cancer Network Chemotherapy Protocol Cisplatin and Pemetrexed for Malignant Mesothelioma (LUWOS 0021) Indication Palliative chemotherapy for malignant mesothelioma of the pleura Eligibility

More information

Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer

Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer Thomas E. Stinchcombe, Mark A. Socinski Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel

More information

Post-operative intrapleural chemotherapy for mesothelioma

Post-operative intrapleural chemotherapy for mesothelioma Post-operative intrapleural chemotherapy for mesothelioma Robert Kratzke, MD John Skoglund Chair for Lung Cancer Research Section of Heme-Onc-Transplant University of Minnesota Medical School Efficacy

More information

January 2013 LONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Summary. Contents

January 2013 LONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Summary. Contents LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Paclitaxel albumin (Abraxane ) as a substitute for docetaxel/paclitaxel for cancer Paclitaxel albumin (Abraxane ) as a substitute for docetaxel/ paclitaxel for

More information

National Horizon Scanning Centre. Vandetanib (Zactima) for advanced or metastatic non-small cell lung cancer. December 2007

National Horizon Scanning Centre. Vandetanib (Zactima) for advanced or metastatic non-small cell lung cancer. December 2007 Vandetanib (Zactima) for advanced or metastatic non-small cell lung cancer December 2007 This technology summary is based on information available at the time of research and a limited literature search.

More information

GUIDELINES FOR THE MANAGEMENT OF LUNG CANCER

GUIDELINES FOR THE MANAGEMENT OF LUNG CANCER GUIDELINES FOR THE MANAGEMENT OF LUNG CANCER BY Ali Shamseddine, MD (Coordinator); as04@aub.edu.lb Fady Geara, MD Bassem Shabb, MD Ghassan Jamaleddine, MD CLINICAL PRACTICE GUIDELINES FOR THE TREATMENT

More information

Summary ID# 13095. Clinical Study Summary: Study H3E-EW-B012

Summary ID# 13095. Clinical Study Summary: Study H3E-EW-B012 Page 1 Summary ID# 13095 Clinical Study Summary: Study H3E-EW-B012 First-line Treatment of Non-Small Cell Lung Cancer under Routine Conditions: Observational Study on Overall Survival Date summary electronically

More information

Gemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer

Gemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer Gemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer Review Article [1] December 01, 2003 By George W. Sledge, Jr, MD [2] Gemcitabine (Gemzar) and paclitaxel show good activity as single

More information

SECOND-LINE CHEMOTHERAPY in advanced non

SECOND-LINE CHEMOTHERAPY in advanced non Gemcitabine as Second-Line Treatment for Advanced Non Small-Cell Lung Cancer: A Phase II Trial By Lucio Crinò, Anna Maria Mosconi, Giorgio Scagliotti, Giovanni Selvaggi, Silvia Novello, Massimo Rinaldi,

More information

London Cancer. Mesothelioma Lung Protocols

London Cancer. Mesothelioma Lung Protocols London Cancer Mesothelioma Lung Protocols Version 0.9 Contents 1. Staging... 3 2. Mesothelioma Summary of Chemotherapy Protocols... 4 3. Mesothelioma Chemotherapy Protocols... 7 3.1. Pemetrexed (Alimta

More information

DECISION AID SET. STAGE IV Non-Small Cell Lung Cancer (NSCLC)

DECISION AID SET. STAGE IV Non-Small Cell Lung Cancer (NSCLC) DECISION AID SET STAGE IV Non-Small Cell Lung Cancer (NSCLC) Dear Clinician: This set of DECISION AIDS is based on ASCO s Clinical Practice Guideline Update on Chemotherapy for Stage IV NSCLC (2009). ASCO

More information

Emerging Drug List GEFITINIB

Emerging Drug List GEFITINIB Generic (Trade Name): Manufacturer: Gefitinib (Iressa ) formerly referred to as ZD1839 AstraZeneca NO. 52 JANUARY 2004 Indication: Current Regulatory Status: Description: Current Treatment: Cost: Evidence:

More information

Out-Patient Chemotherapy for Lung Cancer

Out-Patient Chemotherapy for Lung Cancer Lung Cancer Out-Patient Chemotherapy for Lung Cancer Principles and practice JMAJ 46(12): 542 546, 2003 Shuichi YONEDA Director, Department of Pulmonary Medicine, Saitama Cancer Center Abstract: Recent

More information

New Treatment Options for Breast Cancer

New Treatment Options for Breast Cancer New Treatment Options for Breast Cancer Brandon Vakiner, PharmD., BCOP Clinical Pharmacy Specialist - Oncology The University of Iowa Hospitals and Clinics Assistant Professor (Clinical) University of

More information

Cancer Treatment Reviews

Cancer Treatment Reviews Cancer Treatment Reviews 35 (2009) 364 373 Contents lists available at ScienceDirect Cancer Treatment Reviews journal homepage: www.elsevierhealth.com/journals/ctrv ANTI-TUMOUR TREATMENT Pemetrexed in

More information

Van Cutsem E et al. Proc ASCO 2009;Abstract LBA4509.

Van Cutsem E et al. Proc ASCO 2009;Abstract LBA4509. Efficacy Results from the ToGA Trial: A Phase III Study of Trastuzumab Added to Standard Chemotherapy in First-Line HER2- Positive Advanced Gastric Cancer Van Cutsem E et al. Proc ASCO 2009;Abstract LBA4509.

More information

Gemcitabine and Cisplatin in Patients With Locally Advanced, Recurrent, or Metastatic Head and Neck Cancer: Results of a Phase II Trial

Gemcitabine and Cisplatin in Patients With Locally Advanced, Recurrent, or Metastatic Head and Neck Cancer: Results of a Phase II Trial Gemcitabine and Cisplatin in Patients With Locally Advanced, Recurrent, or Metastatic Head and Neck Cancer: Results of a Phase II Trial Mouhammed J Kyasa, MD Randall L Breau, MD Ehab Hanna, MD James Suen,

More information

Chapter 7: Lung Cancer

Chapter 7: Lung Cancer Chapter 7: Lung Cancer Contents Chapter 7: Lung Cancer... 1 Small Cell... 2 Good PS + Limited stage... 2 Cisplatin/etoposide... 2 Concurrent chemotherapy + XRT... 2 Good / Intermediate PS... 2 Carboplatin

More information

Drug Review Pemetrexed for Injection Alimta

Drug Review Pemetrexed for Injection Alimta Drug Review Pemetrexed for Injection Alimta Reviewer: Jamilah Al-Saedan B.Sc Pharm, King Saud University Introduction Malignant pleural mesothelioma A rare form of cancer. It is a malignant tumor of the

More information

CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early

CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early April 21, 2015 CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early Opdivo Demonstrates Superior Overall Survival Compared to Docetaxel in Patients with Previously-Treated

More information

How valuable is a cancer therapy? It depends on who you ask.

How valuable is a cancer therapy? It depends on who you ask. How valuable is a cancer therapy? It depends on who you ask. Comparing and contrasting the ESMO Magnitude of Clinical Benefit Scale with the ASCO Value Framework in Cancer Ram Subramanian Kevin Schorr

More information

Report on New Patented Drugs - Alimta

Report on New Patented Drugs - Alimta Report on New Patented Drugs - Alimta Under its transparency initiative, the PMPRB publishes the results of the reviews of new patented drugs by Board Staff, for purposes of applying the PMPRB s Excessive

More information

Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing)

Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing) Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015 (minutes for web publishing) Cancer Treatments Subcommittee minutes are published in accordance with the Terms of Reference for the

More information

DOXETAXEL IN PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER PATIENTS: CLINICAL EFFICACY AND QUALITY OF LIFE

DOXETAXEL IN PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER PATIENTS: CLINICAL EFFICACY AND QUALITY OF LIFE SOUTHEAST ASIAN J TROP MED PUBLIC HEALTH DOXETAXEL IN PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER PATIENTS: CLINICAL EFFICACY AND QUALITY OF LIFE Thitiya Sirisinha 1, Suwanee Sirilertrakul 2, Manmana

More information

Clinical Study Report

Clinical Study Report An Open, Multi-Center, Phase II Clinical Trial to Evaluate Efficacy and Safety of Taxol (), UFT, and Leucovorin in Patients with Advanced Gastric Cancer Clinical Study Report 4F, No. 156, Jiankang Rd.,

More information

THE RESULTS OF A large meta-analysis of 52 randomized

THE RESULTS OF A large meta-analysis of 52 randomized Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy By Frances A. Shepherd, Janet Dancey,

More information

Page 1 of 6 Origination Date: 08/13 Revision Date(s): 12/13, 12/14, 04/2015 Developed By: Medical Criteria Committee Effective Date: 10/1/2013

Page 1 of 6 Origination Date: 08/13 Revision Date(s): 12/13, 12/14, 04/2015 Developed By: Medical Criteria Committee Effective Date: 10/1/2013 Moda Health Plan, Inc. Medical Necessity Criteria Subject: Alimta (pemetrexed) Page 1 of 6 Origination Date: 08/13 Revision Date(s): 12/13, 12/14, 04/2015 Developed By: Medical Criteria Committee Effective

More information

IMMUNOMEDICS, INC. February 2016. Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases

IMMUNOMEDICS, INC. February 2016. Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases February 2016 Forward-Looking Statements This presentation, in addition to historical information, contains certain

More information

Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness

Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness Investigators: Paul G. Shekelle, MD, PhD, Director Alicia R. Maher, MD Clinical

More information

Introduction Objective Methods Results Conclusion

Introduction Objective Methods Results Conclusion Introduction Objective Methods Results Conclusion 2 Malignant pleural mesothelioma (MPM) is the most common form of mesothelioma a rare cancer associated with long latency period (i.e. 20 to 40 years),

More information

INITIATING ORAL AUBAGIO (teriflunomide) THERAPY

INITIATING ORAL AUBAGIO (teriflunomide) THERAPY FOR YOUR PATIENTS WITH RELAPSING FORMS OF MS INITIATING ORAL AUBAGIO (teriflunomide) THERAPY WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY Severe liver injury including fatal liver failure has been

More information

PRODUCT MONOGRAPH ALIMTA

PRODUCT MONOGRAPH ALIMTA PRODUCT MONOGRAPH Pr ALIMTA Pemetrexed Disodium for Injection 100 mg or 500 mg pemetrexed per vial Antineoplastic Agent Eli Lilly Canada Inc. 3650 Danforth Avenue Toronto, Ontario M1N 2E8 1-888-545-5972

More information

Principal Investigator: Valerie W. Rusch, MD, FACS, Chief, Thoracic Surgery Memorial Sloan-Kettering Cancer Center

Principal Investigator: Valerie W. Rusch, MD, FACS, Chief, Thoracic Surgery Memorial Sloan-Kettering Cancer Center Protocol 1101-1088 Phase I study of intra-pleural administration of GL-ONC1 in patients with malignant pleural effusion: primary, metastases and mesothelioma Principal Investigator: Valerie W. Rusch, MD,

More information

Drug/Drug Combination: Bevacizumab in combination with chemotherapy

Drug/Drug Combination: Bevacizumab in combination with chemotherapy AHFS Final Determination of Medical Acceptance: Off-label Use of Bevacizumab in Combination with Chemotherapy for the Treatment of Metastatic Breast Cancer Previously Treated with Cytotoxic Chemotherapy

More information

Lung Pathway Group Pemetrexed and Cisplatin in Non-Small Cell Lung Cancer (NSCLC)

Lung Pathway Group Pemetrexed and Cisplatin in Non-Small Cell Lung Cancer (NSCLC) Indication: NICE TA181 First line treatment option in advanced or metastatic non-squamous NSCLC (histology confirmed as adenocarcinoma or large cell carcinoma) Performance status 0-1 Regimen details: Pemetrexed

More information

Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost-Effectiveness

Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost-Effectiveness Department of Veterans Affairs Health Services Research & Development Service Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost-Effectiveness

More information

Redacted Protocol for Journal of Clinical Oncology

Redacted Protocol for Journal of Clinical Oncology Redacted PARAMOUNT Clinical Protocol Page 1 Redacted Protocol for Journal of Clinical Oncology Protocol S124(b) (PARAMOUNT) A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance plus Best Supportive

More information

Efficacy. Table 1. Overall Objective Response. Day 1 Day 2 Day 3 Day 4...Days 5-28. (vincristine infusion) (doxorubicin infusion)

Efficacy. Table 1. Overall Objective Response. Day 1 Day 2 Day 3 Day 4...Days 5-28. (vincristine infusion) (doxorubicin infusion) COST EFFECTIVENESS OF VS IN NEWLY DIAGNOSED MULTIPLE MYELOMA Mohamad A. Hussein, MD, 1 Mark Wildgust, PhD, 2 John Fastenau, MPH, RPh, 3 Catherine Tak Piech, MBA, 3 and the C2000-003 Study Group 1 The Cleveland

More information

Stage I, II Non Small Cell Lung Cancer

Stage I, II Non Small Cell Lung Cancer Stage I, II Non Small Cell Lung Cancer Best Results T1 (less 3 cm) N0 80% 5 year survival No Role Adjuvant Chemotherapy Radiation Therapy Reduces Local Recurrence No Improvement in Survival 1 Staging Mediastinal

More information

Preliminary Results from a Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Family (MiT) Associated Tumors

Preliminary Results from a Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Family (MiT) Associated Tumors Preliminary Results from a Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Family (MiT) Associated Tumors John Goldberg 1 *, George Demetri 2, Edwin Choy 3, Lee Rosen 4, Alberto

More information

Shifting the Paradigm for Maintenance Therapy for Non small-cell Lung Cancer

Shifting the Paradigm for Maintenance Therapy for Non small-cell Lung Cancer J Hong Kong Col Radiol. 2010;13(Suppl):S16-21 ORIGINAL ARTICLE Shifting the Paradigm for Maintenance Therapy for Non small-cell Lung Cancer VHF Lee Department of Clinical Oncology, Queen Mary Hospital,

More information

Attached from the following page is the press release made by BMS for your information.

Attached from the following page is the press release made by BMS for your information. July 22, 2015 CheckMate -025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early (PRINCETON, NJ, July 20, 2015) Bristol-Myers Squibb Company (NYSE:BMY) announced

More information

Lung Cancer and Mesothelioma

Lung Cancer and Mesothelioma Lung Cancer and Mesothelioma Robert Kratzke, M.D. John C. Skoglund Professor of Lung Cancer Research Section of Heme/Onc/Transplant Department of Medicine University of Minnesota Medical School Malignant

More information

Adjuvant Therapy Non Small Cell Lung Cancer. Sunil Nagpal MD Director, Thoracic Oncology Jan 30, 2015

Adjuvant Therapy Non Small Cell Lung Cancer. Sunil Nagpal MD Director, Thoracic Oncology Jan 30, 2015 Adjuvant Therapy Non Small Cell Lung Cancer Sunil Nagpal MD Director, Thoracic Oncology Jan 30, 2015 No Disclosures Number of studies Studies Per Month 12 10 8 6 4 2 0 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3

More information

Everolimus plus exemestane for second-line endocrine treatment of oestrogen receptor positive metastatic breast cancer

Everolimus plus exemestane for second-line endocrine treatment of oestrogen receptor positive metastatic breast cancer LONDON CANCER NEWS DRUGS GROUP RAPID REVIEW Everolimus plus exemestane for second-line endocrine treatment of oestrogen receptor positive metastatic breast cancer Everolimus plus exemestane for second-line

More information

Anti-PD1 Agents: Immunotherapy agents in the treatment of metastatic melanoma. Claire Vines, 2016 Pharm.D. Candidate

Anti-PD1 Agents: Immunotherapy agents in the treatment of metastatic melanoma. Claire Vines, 2016 Pharm.D. Candidate + Anti-PD1 Agents: Immunotherapy agents in the treatment of metastatic melanoma Claire Vines, 2016 Pharm.D. Candidate + Disclosure I have no conflicts of interest to disclose. + Objectives Summarize NCCN

More information

Avastin in Metastatic Breast Cancer

Avastin in Metastatic Breast Cancer Non-interventional study Avastin in Metastatic Breast Cancer ML 21165 / 2007 Clinical Study Report Synopsis ROCHE ML21165 / WiSP Project RH09 / V. 1.0 / 24.06.2013 ROCHE ML21165-2 - Name of Sponsor Roche

More information

CLINICAL POLICY Department: Medical Management Document Name: Opdivo Reference Number: CP.PHAR.121 Effective Date: 07/15

CLINICAL POLICY Department: Medical Management Document Name: Opdivo Reference Number: CP.PHAR.121 Effective Date: 07/15 Page: 1 of 6 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted

More information

Low dose capecitabine is effective and relatively nontoxic in breast cancer treatment.

Low dose capecitabine is effective and relatively nontoxic in breast cancer treatment. 1 Low dose capecitabine is effective and relatively nontoxic in breast cancer treatment. John T. Carpenter, M.D. University of Alabama at Birmingham NP 2508 1720 Second Avenue South Birmingham, AL 35294-3300

More information

SMALL CELL LUNG CANCER

SMALL CELL LUNG CANCER Protocol for Planning and Treatment The process to be followed in the management of: SMALL CELL LUNG CANCER Patient information given at each stage following agreed information pathway 1. DIAGNOSIS New

More information

Pemetrexed in Malignant Pleural Mesothelioma

Pemetrexed in Malignant Pleural Mesothelioma 982 Vol. 11, 982 992, February 1, 2005 Clinical Cancer Research Report from the Food and Drug Administration Pemetrexed in Malignant Pleural Mesothelioma Maitreyee Hazarika, Robert M. White, Jr., Brian

More information

Management of stage III A-B of NSCLC. Hamed ALHusaini Medical Oncologist

Management of stage III A-B of NSCLC. Hamed ALHusaini Medical Oncologist Management of stage III A-B of NSCLC Hamed ALHusaini Medical Oncologist Global incidence, CA cancer J Clin 2011;61:69-90 Stage III NSCLC Includes heterogeneous group of patients with differences in the

More information

Active centers: 2. Number of patients/subjects: Planned: 20 Randomized: Treated: 20 Evaluated: Efficacy: 13 Safety: 20

Active centers: 2. Number of patients/subjects: Planned: 20 Randomized: Treated: 20 Evaluated: Efficacy: 13 Safety: 20 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov

More information

Management of Platinum-Sensitive Recurrent Ovarian Cancer

Management of Platinum-Sensitive Recurrent Ovarian Cancer Management of Platinum-Sensitive Jacobus Pfisterer a and Jonathan A. Ledermann b The majority of patients with ovarian cancer will relapse despite state-of-the-art first-line surgery and chemotherapy.

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Cancer Drug and Biological Products Clinical Data in Marketing Applications U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and

More information

Schedule: Drug Dose iv/infusion/oral q Carboplatin AUC 5 500mls 5% dex/1hr Day 1 Gemcitabine 1200mg/m 2 200mls N. Saline/30mins Days 1 & 8

Schedule: Drug Dose iv/infusion/oral q Carboplatin AUC 5 500mls 5% dex/1hr Day 1 Gemcitabine 1200mg/m 2 200mls N. Saline/30mins Days 1 & 8 Carboplatin/Gemcitabine Lung Cancer (non-small cell) - Advanced Carboplatin AUC 5 500mls 5% dex/1hr Day 1 Gemcitabine 1200mg/m 2 200mls N. Saline/30mins Days 1 & 8 Cycle frequency: Every three weeks Total

More information

Brigham and Women s Hospital, Boston, MA, USA; 2 Verastem, Inc., Boston, MA, USA

Brigham and Women s Hospital, Boston, MA, USA; 2 Verastem, Inc., Boston, MA, USA Determination of Biomarker Response in a Phase II Window of Opportunity Study of Defactinib (VS 6063), a Focal Adhesion Kinase (FAK) Inhibitor, in Patients with Resectable Malignant Pleural Mesothelioma

More information

Clinical Trial Endpoints for the Approval of Non- Small Cell Lung Cancer Drugs and Biologics Guidance for Industry

Clinical Trial Endpoints for the Approval of Non- Small Cell Lung Cancer Drugs and Biologics Guidance for Industry Clinical Trial Endpoints for the Approval of Non- Small Cell Lung Cancer Drugs and Biologics Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug

More information

Role of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases

Role of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases Role of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases R. Shraddha, P.N. Pandit Radium Institute, Patna Medical College and Hospital, Patna, India Abstract NHL is a highly

More information

Lenalidomide (LEN) in Patients with Transformed Lymphoma: Results From a Large International Phase II Study (NHL-003)

Lenalidomide (LEN) in Patients with Transformed Lymphoma: Results From a Large International Phase II Study (NHL-003) Lenalidomide (LEN) in Patients with Transformed Lymphoma: Results From a Large International Phase II Study (NHL-003) Reeder CB et al. Proc ASCO 2010;Abstract 8037. Introduction > Patients (pts) with low-grade

More information

LONDON CANCER NEWS DRUGS GROUP RAPID REVIEW. FOLFIRINOX for first line treatment of advanced pancreatic cancer January 2012

LONDON CANCER NEWS DRUGS GROUP RAPID REVIEW. FOLFIRINOX for first line treatment of advanced pancreatic cancer January 2012 Background LONDON CANCER NEWS DRUGS GROUP RAPID REVIEW FOLFIRINOX for first line treatment of advanced pancreatic cancer January 2012 The incidence of pancreatic cancer in the UK is 9.4/100,000. It is

More information

BCCA Protocol Summary for Advanced Therapy for Relapsed Testicular Germ Cell Cancer Using PACLitaxel, Ifosfamide and CISplatin (TIP)

BCCA Protocol Summary for Advanced Therapy for Relapsed Testicular Germ Cell Cancer Using PACLitaxel, Ifosfamide and CISplatin (TIP) BCCA Protocol Summary for Advanced Therapy for Relapsed Testicular Germ Cell Cancer Using PACLitaxel, Ifosfamide and CISplatin (TIP) Protocol Code Tumour Group Contact Physician UGUTIP Genitourinary Dr.

More information

Mesothelioma. Information for Patients and Families. identifying and evaluating experimental

Mesothelioma. Information for Patients and Families. identifying and evaluating experimental Mesothelioma CLINICAL TRIALS Information for Patients and Families identifying and evaluating experimental treatments table of contents Pg. 2... Phases of a Clinical Trial Pg. 3... Mesothelioma and Clinical

More information

Second-Line Chemotherapy for Non-Small-Cell Lung Cancer

Second-Line Chemotherapy for Non-Small-Cell Lung Cancer Chapter Second-Line Chemotherapy for Non-Small-Cell Lung Cancer 24 Eleni Karapanagiotou and Konstantinos N. Syrigos Contents 24.1 Background... 305 24.2 Docetaxel... 305 24.3 Pemetrexed... 307 24.4 Other

More information

Before, Frank's immune cells could

Before, Frank's immune cells could Before, Frank's immune cells could barely recognize a prostate cancer cell. Now, they are focused on it. Stimulate an immune response against advanced prostate cancer Extend median survival beyond 2 years

More information

MALIGNANT MESOTHELIOMA is an aggressive

MALIGNANT MESOTHELIOMA is an aggressive Cisplatin and Gemcitabine Treatment for Malignant Mesothelioma: A Phase II Study By M.J. Byrne, J.A. Davidson, A.W. Musk, J. Dewar, G. van Hazel, M. Buck, N.H. de Klerk, and B.W.S. Robinson Purpose: We

More information

J Clin Oncol 26:3567-3572. 2008 by American Society of Clinical Oncology INTRODUCTION

J Clin Oncol 26:3567-3572. 2008 by American Society of Clinical Oncology INTRODUCTION VOLUME 26 NUMBER 21 JULY 20 2008 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T Pemetrexed Plus Gemcitabine As First-Line Chemotherapy for Patients With Peritoneal Mesothelioma: Final Report

More information

L Lang-Lazdunski, A Bille, S Marshall, R Lal, D Landau, J Spicer

L Lang-Lazdunski, A Bille, S Marshall, R Lal, D Landau, J Spicer Pleurectomy/decortication, hyperthermic pleural lavage with povidone-iodine and systemic chemotherapy in malignant pleural mesothelioma. A 10-year experience. L Lang-Lazdunski, A Bille, S Marshall, R Lal,

More information

Advancing Personalized Therapy for Advanced Non-Small Cell Lung Cancer

Advancing Personalized Therapy for Advanced Non-Small Cell Lung Cancer GUIDING THE WAY White Paper Advancing Personalized Therapy for Advanced Non-Small Cell Lung Cancer is a serum proteomic test for patients with advanced non-small cell lung cancer that helps healthcare

More information

Taxotere: Clinical Trials in Non-Small Cell Lung Cancer -- Ornstein and Rigas 3 (2): 86...

Taxotere: Clinical Trials in Non-Small Cell Lung Cancer -- Ornstein and Rigas 3 (2): 86... Page 1 of 11 HOME HELP CONTACT US SUBSCRIPTIONS ARCHIVE SEARCH SEARCH RESULT The Oncologist, Vol. 3, No. 2, 86-93, April 1998 1998 AlphaMed Press This Article Taxotere: Clinical Trials in Non-Small Cell

More information

Clinical Trials for Patients with

Clinical Trials for Patients with Clinical Trials for Patients with Malignant Pleural Mesothelioma Lee M. Krug, M.D. Memorial Sloan-Kettering Cancer Center New York, New York Challenges in MPM Clinical Trials Mesothelioma is a rare disease,

More information

Non-small cell lung cancer, advanced or metastatic, switch-therapy after gemcitabine/carboplatin

Non-small cell lung cancer, advanced or metastatic, switch-therapy after gemcitabine/carboplatin COMPENDIA TRANSPARENCY TRACKING FORM DRUG: Docetaxel INDICATION: Non-small cell lung cancer, advanced or metastatic, switch-therapy after gemcitabine/carboplatin COMPENDIA TRANSPARENCY REQUIREMENTS 1 Provide

More information

Kasr El-Aini Center of Clinical Oncology, Faculty of medicine, 2 Chest Department, Faculty of medicine, Cairo University, egypt

Kasr El-Aini Center of Clinical Oncology, Faculty of medicine, 2 Chest Department, Faculty of medicine, Cairo University, egypt Kasr El-aini J. Clin. Oncol. nucl. med. vol., no. 3-4, Jul.-oct. 006:4-47 NEMROCK Original Article Phase II Trial of Cisplatin and Vinorelbine as First-line Therapy in Malignant Pleural Mesothelioma Salah

More information

Future Directions in Clinical Research. Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center

Future Directions in Clinical Research. Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center Future Directions in Clinical Research Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center Outline 1. Status of Cancer Treatment 2. Overview of Clinical Research at UCDCC 3.

More information

pan-canadian Oncology Drug Review Initial Clinical Guidance Report Ramucirumab (Cyramza) for Gastric Cancer September 3, 2015

pan-canadian Oncology Drug Review Initial Clinical Guidance Report Ramucirumab (Cyramza) for Gastric Cancer September 3, 2015 pan-canadian Oncology Drug Review Initial Clinical Guidance Report Ramucirumab (Cyramza) for Gastric Cancer September 3, 2015 DISCLAIMER Not a Substitute for Professional Advice This report is primarily

More information

Strength of Study End Point(s): Progression-free survival

Strength of Study End Point(s): Progression-free survival AHFS Final Determination of Medical Acceptance: Off-label Use of Bevacizumab in Combination with Paclitaxel for the First-line Treatment of Metastatic Breast Cancer Drug/Drug Combination: Bevacizumab and

More information

the standard of care 2009 5/1/2009 Mesothelioma: The standard of care take home messages PILC 2006 Jan.vanmeerbeeck@ugent.be Brussels, March 7, 2009

the standard of care 2009 5/1/2009 Mesothelioma: The standard of care take home messages PILC 2006 Jan.vanmeerbeeck@ugent.be Brussels, March 7, 2009 Mesothelioma: The standard of care Jan.vanmeerbeeck@ugent.be Brussels, March 7, 2009 take home messages PILC 2006 All patients should receive adequate palliation of dyspnea and pain before starting chemotherapy

More information

Chemotherapy for non-small cell lung cancer

Chemotherapy for non-small cell lung cancer Chemotherapy for non-small cell lung cancer This information is an extract from the booklet Understanding lung cancer. You may find the full booklet helpful. We can send you a free copy see page 3. Contents

More information

EVALUATION/PRIORITIZATION CRITERIA: C, L, R, S *to meet requirement 1

EVALUATION/PRIORITIZATION CRITERIA: C, L, R, S *to meet requirement 1 COMPENDIA TRANSPARENCY TRACKING FORM DATE: MAY 2015 PACKET: 111 DRUG: INDICATION: Vinorelbine Tartrate Malignant pleural mesothelioma COMPENDIA TRANSPARENCY REQUIREMENTS 1 Provide criteria used to evaluate/prioritize

More information

Ovarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development

Ovarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development Ovarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development Sanjeeve Bala, MD, MPH Ovarian Cancer Endpoints Workshop FDA White Oak September 3, 2015 Overview Immune agents from

More information

Lung Pathway Group Nintedanib (Vargatef) in advanced Non-Small Cell Lung Cancer (NSCLC)

Lung Pathway Group Nintedanib (Vargatef) in advanced Non-Small Cell Lung Cancer (NSCLC) Lung Pathway Group Nintedanib (Vargatef) in advanced Non-Small Cell Lung Cancer (NSCLC) Indication: In combination with docetaxel in locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma

More information

Second-Line Therapy in Non Small-Cell Lung Cancer: The DELTA Between Different Genotypes Widens

Second-Line Therapy in Non Small-Cell Lung Cancer: The DELTA Between Different Genotypes Widens VOLUME 32 NUMBER 18 JUNE 20 2014 JOURNAL OF CLINICAL ONCOLOGY ONCOLOGY GRAND ROUNDS Second-Line Therapy in Non Small-Cell Lung Cancer: The DELTA Between Different Genotypes Widens Alona Zer and Natasha

More information

Clinical Spotlight in Breast Cancer

Clinical Spotlight in Breast Cancer 2015 European Oncology Congress in Vienna Clinical Spotlight in Breast Cancer Reference Slide Deck Abstract #1815 Impact of Palbociclib Plus Fulvestrant on Global QOL, Functioning, and Symptoms Compared

More information

NATIONAL CANCER DRUG FUND PRIORITISATION SCORES

NATIONAL CANCER DRUG FUND PRIORITISATION SCORES NATIONAL CANCER DRUG FUND PRIORITISATION SCORES Drug Indication Regimen (where appropriate) BORTEZOMIB In combination with dexamethasone (VD), or with dexamethasone and thalidomide (VTD), is indicated

More information