Gemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer

Size: px
Start display at page:

Download "Gemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer"

Transcription

1 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 agents and combined in metastatic breast cancer, and the combination of paclitaxel/trastuzumab (Herceptin) has been shown to prolong time to disease progression and survival significantly in this setting. Preclinical data indicate additive or synergistic effects of gemcitabine and trastuzumab in HER2-positive human breast cancer cell lines. In a phase II trial, patients with HER2-overexpressing metastatic breast cancer who had received no prior chemotherapy for metastatic disease received gemcitabine at 1,200 mg/m2 on days 1 and 8 and paclitaxel at 175 mg/m2 on day 1 every 21 days for six cycles plus trastuzumab at an initial loading dose of 4 mg/kg followed by 2 mg/kg weekly; patients without progressive disease after six cycles continued to receive trastuzumab until disease progression. Overall, objective response was observed in 28 (67%) of 42 evaluable patients, including complete response in 4 (10%) and partial response in 24 (57%); stable disease was observed in 7 (17%) and progressive disease was observed in 6 (14%). Median time to treatment failure was 9+ months. Median overall survival has not yet been reached, but is estimated at approximately 27 months. Significant toxicities apart from neutropenia were uncommon. The triplet combination of gemcitabine, paclitaxel, and trastuzumab is highly active and well tolerated in patients with HER2-overexpressing metastatic breast cancer. Compelling data exist to support the rationale for combining gemcitabine (Gemzar), paclitaxel, and trastuzumab (Herceptin) in the treatment of metastatic breast cancer. Gemcitabine and paclitaxel show good activity as single agents and when used in combination in this setting.[1-7] Phase II studies of the combination have shown objective response rates of 45%,[5] 55%,[6] and 69%,[7] including relatively large numbers of complete responses. The combination of paclitaxel and the monoclonal antibody trastuzumab has been widely studied, and has been shown to improve time to disease progression and survival significantly in patients with HER2-overexpressing tumors compared with chemotherapy alone.[8] The combination of gemcitabine and trastuzumab has been shown to have additive or synergistic effects in HER2-positive human cancer cell lines, including breast cancer cell lines SK-BR-3 and MCF-7.[9] Preliminary results of a phase II study assessing the gemcitabine/ trastuzumab combination in heavily pretreated patients with metastatic breast cancer have been promising.[ 10] We have assessed the triple combination of gemcitabine, paclitaxel, and trastuzumab as first-line therapy in a phase II study in metastatic breast cancer patients.[11] Patients and Methods Eligible patients included those with HER2-positive metastatic breast cancer with HER2 overexpression of 2-3+ on immunohistochemistry (IHC) or positive gene amplification on fluorescence in situ hybridization (FISH). Patients could not have received prior chemotherapy for metastatic disease, and no prior gemcitabine or trastuzumab treatment. Adjuvant taxane treatment was permitted if it had been completed at least 1 year before trial entry. Patients had to have a Karnofsky performance score of 60 with adequate organ function. Exclusion Page 1 of 5

2 criteria included active central nervous system metastasis, congestive heart failure, and recent history of myocardial infarction. Patients received gemcitabine at 1,200 mg/m2 via 30-minute IV infusion on days 1 and 8, paclitaxel at 175 mg/m2 via 3-hour IV infusion on day 1 every 21 days, and trastuzumab given as a 4-mg/kg loading dose via 90- minute IV infusion on day 1 during the first study week and then 2 mg/kg IV over 30 minutes weekly thereafter. Study treatment was administered for a maximum of six 21-day cycles; patients with no progressive disease continued to receive weekly trastuzumab thereafter until disease progression. Responses were assessed after every two cycles of combined chemotherapy and at least every 16 weeks during single-agent trastuzumab treatment. Results A total of 45 patients have been studied to date, with 42 evaluable for treatment response. Patients had a median age of 54 years (range: years) and a median Karnofsky performance score of 90 (range: ). HER2 status was 2+ and 3+ on IHC in 8 (18%) and 11 (24%) patients, respectively, with 3 (7%) being HER2-positive on FISH. For 23 (51%) patients, pathology reports indicated IHC-positive findings without a specified HER2 grade. Sites of metastatic disease included the liver in 24 patients (53%), lung in 22 (49%), bone in 18 (40%), and lymph node/soft tissues in 9 (20%). Toxicities reported among 45 patients are shown in Table 1. Although grade 3 or 4 neutropenia was common, febrile neutropenia and significant infectious complications were rare. Significant gastrointestinal effects were infrequent. Minor fatigue was common, and primarily minor Page 2 of 5

3 taxane-related neuropathy and myalgia were observed. Although four patients reported pulmonary adverse events (grade 3), the adverse events appeared to be related to underlying breast cancer rather than chemotherapy. Clinical congestive heart failure was observed in three patients who developed absolute left-ventricular ejection fractions < 45%. One of these patients experienced a decrease in left-ventricular ejection fraction of 15%; the other two patients entered the study with ejection fractions of approximately 50% and became symptomatic with smaller decreases in ejection fraction. All of these patients discontinued treatment and subsequently recovered. Objective responses were observed in 28 (67%) of 42 evaluable patients, consisting of complete response in 4 (10%) and partial response in 24 (57%). Seven patients (17%) had stable disease; 6 patients (14%) had progressive disease. Of the three patients who were nonevaluable for response, two were removed from the study before completing the first cycle of chemotherapy. Time to treatment failure, defined as time to disease progression, death, or discontinuation due to toxicity, and overall survival are shown in Figure 1. Median time to treatment failure was 283 days (approximately 9 months). Median survival has not yet been reached in the population, but it is estimated to be approximately 27 months. Conclusions The triplet combination of gemcitabine, paclitaxel, and trastuzumab is highly active and well tolerated in patients with HER2-positive metastatic breast cancer. The trial was community- based, and recruitment of patients with HER2 2+ IHC status without confirmation of HER2 overexpression by FISH was common practice during the period of initial enrollment in this trial ( ). The absence of the grading and FISH confirmation suggests that this study population is less highly selected for HER2 overexpression than would be typical of current trials. It is likely that the response rate would have been higher than the 67% rate observed in this population if patient selection based on HER2 status had been more precise. Significant toxicities were minimal with the triplet regimen. Although pulmonary toxicity has been reported in 1.4% of all patients treated with gemcitabine, it was not a significant problem in the current study. The gemcitabine/paclitaxel/ trastuzumab triplet is a promising regimen for treatment of HER2- positive metastatic breast cancer. Page 3 of 5

4 Disclosures: The author(s) have no significant financial interest or other relationship with the manufacturers of any products or providers of any service mentioned in this article. Page 4 of 5

5 References: 1. Carmichael J, Possinger K, Phillip P, et al: Advanced breast cancer: A phase II trial with gemcitabine. J Clin Oncol 13: , Possinger K, Kaufmann M, Coleman R, et al: Phase II study of gemcitabine as firstline chemotherapy in patients with advanced or metastatic breast cancer. Anticancer Drugs 10: , Spielmann M, Llombart-Cussac A, Kalla S, et al: Single-agent gemcitabine is active in previously treated metastatic breast cancer. Oncology (Basel) 60: , Blackstein M, Vogel CL, Ambinder R, et al: Gemcitabine as first-line therapy in patients with metastatic breast cancer: A phase II trial. Oncology (Basel) 62:2-8, Sanchez-Rovira, P, Medina MB, Mohendano N, et al: Results from a phase II study of gemcitabine in combination with paclitaxel in metastatic breast cancer (abstract). Ann Oncol 9(suppl 4):A77P, Colomer R, Llombart A, Lluch A, et al: Biweekly paclitaxel and gemcitabine in advanced breast cancer: Phase II trial and predictive value of Her2 extracellular domain (ECD) (abstract 373). Proc Am Soc Clin Oncol 19:97a, 2000; Ann Oncol (in press). 7. Murad AM, Guimaraes RC, Aragao BC, et al: Gemcitabine and paclitaxel as salvage therapy in metastatic breast cancer. Am J Clin Oncol 24: , Slamon DJ, Leyland-Jones B, Shak S, et al: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344: , Bunn PA Jr, Helfrich B, Soriano AF, et al: Expression of Her-2/neu in human lung cancer cell lines by immunohistochemistry and fluorescence in situ hybridization and its relationship to in vitro cytotoxicity by trastuzumab and chemotherapeutic agents. Clin Cancer Res 7: , O'Shaughnessy J: Gemcitabine and trastuzumab in metastatic breast cancer. Semin Oncol 30(suppl 3):22-26, Miller KD, Sisk J, Ausari R, et al: Gemcitabine, paclitaxel, and trastuzumab in metastatic breast cancer. Oncology (Huntingt) 15(suppl 3):38-40, Source URL: c-breast-cancer Links: [1] [2] Page 5 of 5

Avastin in breast cancer: Summary of clinical data

Avastin in breast cancer: Summary of clinical data Avastin in breast cancer: Summary of clinical data Worldwide, over one million people are diagnosed with breast cancer every year 1. It is the most frequently diagnosed cancer in women 1,2, and the leading

More information

BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA)

BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA) BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer using Trastuzumab Emtansine (KADCYLA) Protocol Code Tumour Group Contact Physician UBRAVKAD Breast Dr Stephen Chia ELIGIBILITY:

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

Avastin in breast cancer: Summary of clinical data

Avastin in breast cancer: Summary of clinical data Avastin in breast cancer: Summary of clinical data Worldwide, over one million people are diagnosed with breast cancer every year 1. It is the most frequently diagnosed cancer in women 1,2, and the leading

More information

Symposium article. Trastuzumab combined with chemotherapy for the treatment of HER2-positive metastatic breast cancer: Pivotal trial data

Symposium article. Trastuzumab combined with chemotherapy for the treatment of HER2-positive metastatic breast cancer: Pivotal trial data Annals of Oncology 12 (Suppl. I): S57-S62, 2001. 2001 Kluwer Academic Publishers. Primed in the Netherlands. Symposium article Trastuzumab combined with chemotherapy for the treatment of HER2-positive

More information

Monoclonal Antibodies in Cancer. Ralph Schwall, PhD Associate Director, Translational Oncology Genentech, Inc.

Monoclonal Antibodies in Cancer. Ralph Schwall, PhD Associate Director, Translational Oncology Genentech, Inc. Monoclonal Antibodies in Cancer Ralph Schwall, PhD Associate Director, Translational Oncology Genentech, Inc. Disclaimer I had nothing to do with Herceptin Using lessons learned in new antibody projects

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

Appendix One. HER2-positive early breast cancer, its treatment and prognosis

Appendix One. HER2-positive early breast cancer, its treatment and prognosis Appendix One. HER2-positive early breast cancer, its treatment and prognosis Breast cancer and HER2/neu over-expression Health need is one of PHARMAC s nine decision criteria (http://www.pharmac.govt.nz/pdf/231205.pdf

More information

Clinical trials of Herceptin 1 (trastuzumab)

Clinical trials of Herceptin 1 (trastuzumab) European Journal of Cancer 37 (2001) S18±S24 www.ejconline.com Clinical trials of Herceptin 1 (trastuzumab) J. Baselga * Department of Medical Oncology, Hospital General Universitari Vall d'hebron, Psg.

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

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy Ado-Trastuzumab Emtansine (Trastuzumab-DM1) for Treatment of File Name: Origination: Last CAP Review: Next CAP Review: Last Review: ado_trastuzumab_emtansine_(trastuzumab-dm1)_for_treatment_of_her-2_positivemalignancies

More information

Trastuzumab (Herceptin ) for patients with metastatic breast cancer

Trastuzumab (Herceptin ) for patients with metastatic breast cancer JULY 2007 Incorporates published evidence to November 2006 INFORMATION ABOUT Trastuzumab (Herceptin ) for patients with metastatic breast cancer This information has been developed to help you understand

More information

What s New With HER2?

What s New With HER2? What s New With HER2? Trastuzumab emtansine and pertuzumab for metastatic breast cancer Lindsay Livingston Pharmacist CancerCare Manitoba October 3, 2014 Presenter Disclosure Faculty: Lindsay Livingston

More information

BREAST CANCER UPDATE C H R I S S Z Y A R T O, D O G E N E S E E H E M A T O L O G Y O N C O L O G Y F L I N T, M I

BREAST CANCER UPDATE C H R I S S Z Y A R T O, D O G E N E S E E H E M A T O L O G Y O N C O L O G Y F L I N T, M I BREAST CANCER UPDATE C H R I S S Z Y A R T O, D O G E N E S E E H E M A T O L O G Y O N C O L O G Y F L I N T, M I Overview Why is it important to understand breast cancer? Choosing wisely Appropriateness

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

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

BRAVPTRAD. Protocol Code: Breast. Tumour Group: Dr. Stephen Chia. Contact Physician:

BRAVPTRAD. Protocol Code: Breast. Tumour Group: Dr. Stephen Chia. Contact Physician: BCCA Protocol Summary for Palliative Therapy for Metastatic Breast Cancer Using PERTuzumab, Trastuzumab (HERCEPTIN), and DOCEtaxel as First-Line Treatment for Advanced Breast Cancer Protocol Code: Tumour

More information

Chugai Pharmaceutical Co., Ltd. Oncology Area, Scientific Group 2, Breast Cancer Group Takehiro Yamaguchi, Herceptin Product Manager

Chugai Pharmaceutical Co., Ltd. Oncology Area, Scientific Group 2, Breast Cancer Group Takehiro Yamaguchi, Herceptin Product Manager Anti-malignant Tumor Agent with Anti-HER2 Humanized Monoclonal Antibody: Biologics, Designated drug, Prescription drug HERCEPTIN Injection 60 HERCEPTIN Injection 150 Trastuzumab (genetical recombination)

More information

London Cancer New Drugs Group APC/DTC Briefing

London Cancer New Drugs Group APC/DTC Briefing London Cancer New Drugs Group APC/DTC Briefing Continued use of trastuzumab following disease progression in metastatic breast cancer Contents Summary 1 Background 2 Adverse events/safety issues Health

More information

GUIDELINES ADJUVANT SYSTEMIC BREAST CANCER

GUIDELINES ADJUVANT SYSTEMIC BREAST CANCER GUIDELINES ADJUVANT SYSTEMIC BREAST CANCER Author: Dr Susan O Reilly On behalf of the Breast CNG Written: December 2008 Agreed at CNG: June 2009 & June 2010 Review due: June 2011 Guidelines Adjuvant Systemic

More information

5.04.20. Perjeta. Perjeta (pertuzumab) Description

5.04.20. Perjeta. Perjeta (pertuzumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.04.20 Subject: Perjeta Page: 1 of 5 Last Review Date: June 19, 2015 Perjeta Description Perjeta (pertuzumab)

More information

PRO: Pathologic Complete Response Does Predict Outcome for Early Stage Breast Cancer Patients

PRO: Pathologic Complete Response Does Predict Outcome for Early Stage Breast Cancer Patients PO: Pathologic Complete esponse Does Predict Outcome for Early Stage Breast Cancer Patients Amelia B. Zelnak, MD, MSc Assistant Professor of Hematology and Medical Oncology Winship Cancer Institute Emory

More information

Monitoring Soluble HER2 Levels in Patients with Metastatic Breast Cancer

Monitoring Soluble HER2 Levels in Patients with Metastatic Breast Cancer Transcript Details This is a transcript of a continuing medical education (CME) activity accessible on the ReachMD network. Additional media formats for the activity and full activity details (including

More information

EDITH A. PEREZ. Multidisciplinary Breast Clinic, Mayo Clinic and Mayo Foundation, Jacksonville, Florida, USA

EDITH A. PEREZ. Multidisciplinary Breast Clinic, Mayo Clinic and Mayo Foundation, Jacksonville, Florida, USA The Oncologist Breast Cancer Carboplatin in Combination Therapy for Metastatic Breast Cancer EDITH A. PEREZ Multidisciplinary Breast Clinic, Mayo Clinic and Mayo Foundation, Jacksonville, Florida, USA

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

Activity of pemetrexed in thoracic malignancies

Activity of pemetrexed in thoracic malignancies 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

More information

Adjuvant treatment of breast cancer patients with trastuzumab

Adjuvant treatment of breast cancer patients with trastuzumab doi:10.2478/v10019-007-0020-y review Adjuvant treatment of breast cancer patients with trastuzumab Erika Matos, Tanja Čufer Institute of Oncology Ljubljana, Department of Medical Oncology, Ljubljana, Slovenia

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

Miquel Àngel Seguí Palmer

Miquel Àngel Seguí Palmer Miquel Àngel Seguí Palmer HER2+ Breast Cancer is characterized by overexpression of HER2 receptors HER2+ Breast Cancer is characterized by overexpression of HER2 receptors HER2+ status is associated with

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

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

A Phase 1 Study of MM-302, a HER2- targeted PEGylated liposomal doxorubicin, in Patients with HER2-positive Metastatic Breast Cancer (MBC)

A Phase 1 Study of MM-302, a HER2- targeted PEGylated liposomal doxorubicin, in Patients with HER2-positive Metastatic Breast Cancer (MBC) A Phase 1 Study of MM-32, a HER2- targeted PEGylated liposomal doxorubicin, in Patients with HER2-positive Metastatic Breast Cancer (MBC) P LoRusso 1, I Krop 2, K Miller 3, C Ma 4, BA Siegel 4, AF Shields

More information

LAPATINIB-BASED THERAPY FOR WOMEN WITH ADVANCED/ METASTATIC HER2 POSITIVE BREAST CANCER

LAPATINIB-BASED THERAPY FOR WOMEN WITH ADVANCED/ METASTATIC HER2 POSITIVE BREAST CANCER 146 Experimental Oncology 37, 146 150, 2015 (June) Exp Oncol 2015 37, 2, 146 150 LAPATINIB-BASED THERAPY FOR WOMEN WITH ADVANCED/ METASTATIC HER2 POSITIVE BREAST CANCER J. Zekri 1, 2, M. Mokhtar 3, S.M.

More information

Metastatic breast cancer, HER2 overexpression, first-line therapy in combination with a taxane and trastuzumab

Metastatic breast cancer, HER2 overexpression, first-line therapy in combination with a taxane and trastuzumab COMPENDIA TRANSPARENCY TRACKING FORM DRUG: Carboplatin INDICATION: Metastatic breast cancer, HER2 overexpression, first-line therapy in combination with a taxane and trastuzumab COMPENDIA TRANSPARENCY

More information

HER2 Status: What is the Difference Between Breast and Gastric Cancer?

HER2 Status: What is the Difference Between Breast and Gastric Cancer? Ask the Experts HER2 Status: What is the Difference Between Breast and Gastric Cancer? Bharat Jasani MBChB, PhD, FRCPath Marco Novelli MBChB, PhD, FRCPath Josef Rüschoff, MD Robert Y. Osamura, MD, FIAC

More information

What is the optimal sequence of anti-her2 therapy in metastatic breast cancer?

What is the optimal sequence of anti-her2 therapy in metastatic breast cancer? What is the optimal sequence of anti-her2 therapy in metastatic breast cancer? David Miles Mount Vernon Cancer Centre Northwood Middlesex UKBCM mee)ng: London 2013 Herceptin plus a taxoid extends survival

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

Trastuzumab for the treatment of HER2-positive metastatic gastric cancer

Trastuzumab for the treatment of HER2-positive metastatic gastric cancer Trastuzumab for the treatment of HER2-positive metastatic gastric cancer Issued: November 2010 guidance.nice.org.uk/ta208 NICE has accredited the process used by the Centre for Health Technology Evaluation

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

Trastuzumab (Herceptin ) for patients with early breast cancer

Trastuzumab (Herceptin ) for patients with early breast cancer JULY 2007 Incorporates published evidence to November 2006 INFORMATION ABOUT Trastuzumab (Herceptin ) for patients with early breast cancer This information has been developed to help you understand and

More information

trastuzumab, 600mg/5mL solution for injection (Herceptin ) SMC No. (928/13) Roche Products Ltd

trastuzumab, 600mg/5mL solution for injection (Herceptin ) SMC No. (928/13) Roche Products Ltd trastuzumab, 600mg/5mL solution for injection (Herceptin ) SMC No. (928/13) Roche Products Ltd 06 December 2013 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

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

HER2 Testing in Breast Cancer

HER2 Testing in Breast Cancer HER2 Testing in Breast Cancer GAIL H. VANCE, M.D. AGT MEETING JUNE 13, 2014 LOUISVILLE, KENTUCKY No Conflict of Interest to Report Human Epidermal Growth Factor Receptor 2-HER2 Human epidermal growth factor

More information

Starting treatment early with PERJETA

Starting treatment early with PERJETA Starting treatment early with PERJETA A TREATMENT FOR HER2-POSITIVE EARLY BREAST CANCER GIVEN BEFORE SURGERY HER2 = human epidermal growth factor receptor 2. What does PERJETA treat? PERJETA (pertuzumab)

More information

OI PARP ΑΝΑΣΤΟΛΕΙΣ ΣΤΟΝ ΚΑΡΚΙΝΟ ΤΟΥ ΜΑΣΤΟΥ ΝΙΚΟΛΑΙΔΗ ΑΔΑΜΑΝΤΙΑ ΠΑΘΟΛΟΓΟΣ-ΟΓΚΟΛΟΓΟΣ Β ΟΓΚΟΛΟΓΙΚΗ ΚΛΙΝΙΚΗ ΝΟΣ. ΜΗΤΕΡΑ

OI PARP ΑΝΑΣΤΟΛΕΙΣ ΣΤΟΝ ΚΑΡΚΙΝΟ ΤΟΥ ΜΑΣΤΟΥ ΝΙΚΟΛΑΙΔΗ ΑΔΑΜΑΝΤΙΑ ΠΑΘΟΛΟΓΟΣ-ΟΓΚΟΛΟΓΟΣ Β ΟΓΚΟΛΟΓΙΚΗ ΚΛΙΝΙΚΗ ΝΟΣ. ΜΗΤΕΡΑ OI PARP ΑΝΑΣΤΟΛΕΙΣ ΣΤΟΝ ΚΑΡΚΙΝΟ ΤΟΥ ΜΑΣΤΟΥ ΝΙΚΟΛΑΙΔΗ ΑΔΑΜΑΝΤΙΑ ΠΑΘΟΛΟΓΟΣ-ΟΓΚΟΛΟΓΟΣ Β ΟΓΚΟΛΟΓΙΚΗ ΚΛΙΝΙΚΗ ΝΟΣ. ΜΗΤΕΡΑ Study Overview Inhibition of poly(adenosine diphosphate [ADP]-ribose) polymerase

More information

CLINICAL POLICY Department: Medical Management Document Name: HER2 Breast Cancer Treatments

CLINICAL POLICY Department: Medical Management Document Name: HER2 Breast Cancer Treatments Page: 1 of 11 Specialist Review: Revised: 06/13 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review

More information

18.5 Percent Overall Response Rate Observed in Pembrolizumab-Treated Patients with this Aggressive Form of Breast Cancer

18.5 Percent Overall Response Rate Observed in Pembrolizumab-Treated Patients with this Aggressive Form of Breast Cancer News Release Media Contacts: Annick Robinson Investor Contacts: Joseph Romanelli (514) 837-2550 (908) 740-1986 Stephanie Lyttle NATIONAL Public Relations (514) 843-2365 Justin Holko (908) 740-1879 Merck

More information

Biomarker Trends in Breast Cancer Research

Biomarker Trends in Breast Cancer Research WHITE PAPER Biomarker Trends in Breast Cancer Research Jason Hill, PhD, Associate Director, External Science Affairs, Quintiles Quintiles examines the novel drug combinations and mechanisms of action that

More information

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

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

Receptor conversion in distant breast cancer metastases. Breast cancer metastases: A spitting image of their primary?

Receptor conversion in distant breast cancer metastases. Breast cancer metastases: A spitting image of their primary? Receptor conversion in distant breast cancer metastases Breast cancer metastases: A spitting image of their primary? Introduction Breast cancer is the leading cause of female cancer death worldwide (13,000

More information

Role of Gemcitabine in the Treatment of Advanced and Metastatic Breast Cancer

Role of Gemcitabine in the Treatment of Advanced and Metastatic Breast Cancer Review Oncology 2003;64:191 206 DOI: 10.1159/000069315 Role of Gemcitabine in the Treatment of Advanced and Metastatic Breast Cancer Volker Heinemann Medical Clinic III, Klinikum Grosshadern, Munich, Germany

More information

National Institute for Health and Clinical Excellence

National Institute for Health and Clinical Excellence Comment 1: the draft remit Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer Table of responses to consultee and commentator comments on the draft scope

More information

Evaluating the Efficiency of Targeted Designs for Randomized Clinical Trials

Evaluating the Efficiency of Targeted Designs for Randomized Clinical Trials Vol. 0, 6759 6763, October 5, 004 Clinical Cancer Research 6759 Perspective Evaluating the Efficiency of Targeted Designs for Randomized Clinical Trials Richard Simon and Aboubakar Maitournam Biometric

More information

REF/2011/06/002450 CTRI Website URL - http://ctri.nic.in

REF/2011/06/002450 CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 14 Jul 2016 07:52:01 GMT) CTRI Number Last Modified On 08/07/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study

More information

Recommendation Strength Strong, supported by the evidence and expert consensus. Recommendation Benefit/Harm Evidence Quality

Recommendation Strength Strong, supported by the evidence and expert consensus. Recommendation Benefit/Harm Evidence Quality CHEMO- AND TARGETED THERAPY FOR WOMEN WITH HER2 NEGATIVE (OR UNKNOWN) ADVANCED BREAST Benefit/Harm Evidence Quality 1: Endocrine therapy, rather than chemotherapy, should be offered as the standard firstline

More information

Cytotoxic Therapy in Metastatic Breast Cancer

Cytotoxic Therapy in Metastatic Breast Cancer Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer Cytotoxic Therapy in Metastatic Breast Cancer Cytotoxic Therapy in Metastatic Breast Cancer Version 2002: von Minckwitz Versions

More information

Cycle frequency: Every three weeks Total number of cycles: 4 (Adjuvant) 6 (Palliative)

Cycle frequency: Every three weeks Total number of cycles: 4 (Adjuvant) 6 (Palliative) AC (Doxorubicin/Cyclophosphamide) Breast Cancer Adjuvant, Palliative Doxorubicin 60mg/m 2 iv Day 1 Cyclophosphamide 600mg/m 2 iv Day 1 Cycle frequency: Every three weeks Total number of cycles: 4 (Adjuvant)

More information

Metastatic breast cancer represents an incurable condition associated with an average survival time of 18 to 24 months.

Metastatic breast cancer represents an incurable condition associated with an average survival time of 18 to 24 months. TACT-2C Trial A phase II randomized, open-label study evaluating the addiction of trastuzumabto (nabtm)-paclitaxel as first line treatment in primary HER2 negative metastatic breast cancer patients with

More information

Docetaxel + Carboplatin + Trastuzumab (TCH) Adjuvant Breast Cancer

Docetaxel + Carboplatin + Trastuzumab (TCH) Adjuvant Breast Cancer Docetaxel + Carboplatin + Trastuzumab (TCH) Adjuvant Breast Cancer Background: A non-anthracycline based regimen for high-risk, HER 2 positive breast cancer in the adjuvant setting (BCIRG 006). Patient

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

PATHOLOGY. HercepTestTM. Product Information

PATHOLOGY. HercepTestTM. Product Information PATHOLOGY HercepTestTM Product Information CLINICAL TRIALS HercepTest The First and Foremost Dako s pharmdx HercepTest was the first FDA-approved assay developed exclusively to aid physicians in identifying

More information

WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS,

WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, FACT SHEET BRANDED/GENERIC NAME: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) ABRAXANE is an albumin-bound form of paclitaxel with a

More information

HER2 FISH pharmdx. Assay Kit

HER2 FISH pharmdx. Assay Kit PATHOLOGY HER2 FISH pharmdx Assay Kit HER2 FISH pharmdx Clarity You Can Count On Reliable Results at a Glance The robust HER2 FISH pharmdx assay offers bright and distinct signals for easy and fast reading

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

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

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

Ganetespib and Docetaxel in NSCLC

Ganetespib and Docetaxel in NSCLC Ganetespib and Docetaxel in NSCLC Suresh S. Ramalingam, MD Associate Professor Director, Division of Medical Oncology Emory University Winship Cancer Institute 1 Role of Docetaxel in Advanced NSCLC Docetaxel

More information

FDA grants Roche s Perjeta regimen Priority Review for use before surgery in HER2-positive early-stage breast cancer

FDA grants Roche s Perjeta regimen Priority Review for use before surgery in HER2-positive early-stage breast cancer Media Release Basel, 2 July, 2013 FDA grants Roche s Perjeta regimen Priority Review for use before surgery in HER2-positive early-stage breast cancer Application follows proposed new FDA pathway designed

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

a Phase 2 prostate cancer clinical trial is ongoing. Table 2: Squalamine vs Standard-of-care literature

a Phase 2 prostate cancer clinical trial is ongoing. Table 2: Squalamine vs Standard-of-care literature PRODUCT FACT SHEET Spring 2007 MISSION STATEMENT Genaera Corporation is a biopharmaceutical company with a focus on metabolic and respiratory diseases. The compounds in the Genaera pipeline address signal

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

EC TH Neoadjuvant Breast Cancer

EC TH Neoadjuvant Breast Cancer EC TH Neoadjuvant Breast Cancer Background: Neoadjuvant chemotherapy for inoperable locally advanced, inflammatory breast cancer or to downsize tumour prior to surgery. For patients with HER2 positive

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

Prognosis of Women With Metastatic Breast Cancer by HER2 Status and Trastuzumab Treatment: An Institutional-Based Review

Prognosis of Women With Metastatic Breast Cancer by HER2 Status and Trastuzumab Treatment: An Institutional-Based Review VOLUME 28 NUMBER 1 JANUARY 1 2010 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T Prognosis of Women With Metastatic Breast Cancer by HER2 Status and Trastuzumab Treatment: An Institutional-Based

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

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

Metastatic Breast Cancer 201. Carolyn B. Hendricks, MD October 29, 2011

Metastatic Breast Cancer 201. Carolyn B. Hendricks, MD October 29, 2011 Metastatic Breast Cancer 201 Carolyn B. Hendricks, MD October 29, 2011 Overview Is rebiopsy necessary at the time of recurrence or progression of disease? How dose a very aggressive treatment upfront compare

More information

J Clin Oncol 22:3700-3704. 2004 by American Society of Clinical Oncology INTRODUCTION

J Clin Oncol 22:3700-3704. 2004 by American Society of Clinical Oncology INTRODUCTION VOLUME 22 NUMBER 18 SEPTEMBER 15 2004 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T Effect of Doxorubicin Plus Cyclophosphamide on Left Ventricular Ejection Fraction in With Breast Cancer in

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

Nonanthracycline Containing Docetaxel-Based Combinations in Metastatic Breast Cancer

Nonanthracycline Containing Docetaxel-Based Combinations in Metastatic Breast Cancer nanthracycline Containing Docetaxel-Based Combinations in Metastatic Breast Cancer JOHN CROWN St. Vincent s Hospital, Dublin, Ireland Key Words. MBC Docetaxel Cisplatin Carboplatin Vinorelbine Gemcitabine

More information

LOOKING FORWARD PUMA BIOTECHNOLOGY, INC. 2014 ANNUAL REPORT

LOOKING FORWARD PUMA BIOTECHNOLOGY, INC. 2014 ANNUAL REPORT LOOKING FORWARD PUMA BIOTECHNOLOGY, INC. 2014 ANNUAL REPORT Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of

More information

Biologic Basis of Breast Cancer Treatment

Biologic Basis of Breast Cancer Treatment Biologic Basis of Breast Cancer Treatment Julie R. Gralow, M.D. Director, Breast Medical Oncology Jill Bennett Endowed Professor of Breast Cancer Professor, Global Health University of Washington School

More information

Breast cancer. A guide for journalists on breast cancer and its treatment

Breast cancer. A guide for journalists on breast cancer and its treatment Breast cancer A guide for journalists on breast cancer and its treatment Contents Contents 2 3 Section 1: Breast Cancer 4 i. What is breast cancer? 4 ii. Types of breast cancer 4 iii. Causes and risk factors

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

AIDS IN IDENTIFYING CANDIDATES FOR HER2-TARGETED THERAPY

AIDS IN IDENTIFYING CANDIDATES FOR HER2-TARGETED THERAPY AIDS IN IDENTIFYING CANDIDATES FOR HER2-TARGETED THERAPY THE HERMARK BREAST CANCER ASSAY HERmark is based on our proprietary VeraTag technology that precisely quantifies HER2 proteins and protein complexes

More information

Trastuzumab Use in Breast Cancer: Clinical Issues

Trastuzumab Use in Breast Cancer: Clinical Issues Trastuzumab can be beneficial when used alone or with cytotoxic antitumor agents in selected patients with breast cancer. James Rosenquist. Tampa-New York 1188, 1975. Lithograph, 36 74. Courtesy of Graphicstudio/USF.

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

New strategies in anticancer therapy

New strategies in anticancer therapy 癌 症 診 療 指 引 簡 介 及 臨 床 應 用 New strategies in anticancer therapy 中 山 醫 學 大 學 附 設 醫 院 腫 瘤 內 科 蔡 明 宏 醫 師 2014/3/29 Anti-Cancer Therapy Surgical Treatment Radiotherapy Chemotherapy Target Therapy Supportive

More information

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety,

NCT Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, NCT02020291 Preliminary Report: Phase I Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of Foxy-5 in Patients with Metastatic Breast, Colon or Prostate

More information

Published Ahead of Print on August 9, 2016 as 10.1200/JCO.2015.61.8983. J Clin Oncol 34. 2016 by American Society of Clinical Oncology INTRODUCTION

Published Ahead of Print on August 9, 2016 as 10.1200/JCO.2015.61.8983. J Clin Oncol 34. 2016 by American Society of Clinical Oncology INTRODUCTION Published Ahead of Print on August 9, 2016 as 10.1200/JCO.2015.61.8983 The latest version is at http://jco.ascopubs.org/cgi/doi/10.1200/jco.2015.61.8983 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E

More information

Chemotherapy for bladder cancer. BCAN Denver September 24, 2011

Chemotherapy for bladder cancer. BCAN Denver September 24, 2011 Chemotherapy for bladder cancer BCAN Denver September 24, 2011 University of Colorado School of Medicine Founded in 1883 500,000 patients a year 100,00 cancer visits annually Overview Indications for chemotherapy

More information

Ryutaro Mori and Yasuko Nagao

Ryutaro Mori and Yasuko Nagao 557376SMO0010.1177/2050312114557376SAGE Open MedicineMori and Nagao research-article2014 Original Article SAGE Open Medicine Efficacy of chemotherapy after hormone therapy for hormone receptor positive

More information

DECISION AND SUMMARY OF RATIONALE

DECISION AND SUMMARY OF RATIONALE DECISION AND SUMMARY OF RATIONALE Indication under consideration Clinical evidence Everolimus in combination with exemestane hormone therapy for oestrogen receptor positive locally advanced or metastatic

More information

A Medical Device Strategy To Inhibit HER2+ Breast Cancer Progression

A Medical Device Strategy To Inhibit HER2+ Breast Cancer Progression A Medical Device Strategy To Inhibit HER2+ Breast Cancer Progression September 27, 2011 James A. Joyce Chairman & CEO, Aethlon Medical, Inc jj@aethlonmedical.com Last week, we introduced HER2osome as a

More information

Pharmacogenomic markers in EGFR-targeted therapy of lung cancer

Pharmacogenomic markers in EGFR-targeted therapy of lung cancer Pharmacogenomic markers in EGFR-targeted therapy of lung cancer Rafal Dziadziuszko, MD, PhD University of Colorado Cancer Center, Aurora, CO, USA Medical University of Gdansk, Poland EMEA Workshop on Biomarkers,

More information

Are CAR T-Cells the Solution for Chemotherapy Refractory Diffuse Large B-Cell Lymphoma? Umar Farooq, MD University of Iowa Hospitals and Clinics

Are CAR T-Cells the Solution for Chemotherapy Refractory Diffuse Large B-Cell Lymphoma? Umar Farooq, MD University of Iowa Hospitals and Clinics Are CAR T-Cells the Solution for Chemotherapy Refractory Diffuse Large B-Cell Lymphoma? Umar Farooq, MD University of Iowa Hospitals and Clinics Disclosure(s) I do not intend to discuss an off-label use

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

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

Protein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer

Protein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer Protein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer Dan Vogl Lay Abstract Early stage non-small cell lung cancer can be cured

More information