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

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

2 No Disclosures

3 Number of studies Studies Per Month

4 Demographics Total 130 patients between the ages of 51 to Males - 64 White, 2 Black, 1 Asian, 1 no race given 62 females - 59 White. 3 no race given 27 abnormals had follow up less than 12 months, and 2 had biopsy requests, 1 positive for NSCLCa 29 of abnormals had a Family History of Cancer, 1 adopted (unknown). 130 patients average smoking = 1.09 packs per day with average smoking history of 40 pack years. 4

5 Demographics Stated Exposure: Second hand smoke (82) Farming exposure (45) Cadmium (33) Asbestos (32) Diesel (34) Silica (20) Arsenic (17) Chromium (12) Beryllium (6) Coal (9) Soot (12) Nickel (6) Radon (3)

6 Current Data Abnormals 20 normals 60 solid 5 GGO 144 Non Cancerous (could be multiples) 2 size not given 3 < 5 mm 45 COPD 22 less than 5 mm 27 Coronary Calcs 12 = 5 mm 26 Calc granuloma 24 greater than 5 mm 53 Others

7

8 LACE Meta Analysis

9 LACE Included trials

10 IALT Trial N Engl J Med 2004;350:

11 IALT Largest, platinum-based adjuvant chemotherapy - International Adjuvant Lung Cancer Trial (IALT) 1867 patients with resected stage I, II, or III NSCLC were randomly assigned to three or four cycles of cisplatin-based chemotherapy or to observation. Median follow-up of 56 months Five-year survival rate was higher with adjuvant chemotherapy (44.5 versus 40.4 percent, hazard ratio [HR] 0.86, 95% CI ). Subsequent report with median follow-up of 7.5 years, adjuvant chemotherapy was associated with a significant improvement in disease-free survival (HR 0.88, 95% CI ) and a trend toward improved overall survival (hazard ratio [HR] 0.91, 95% CI , p = 0.10). There was a trend toward an increase in nonlung cancer deaths over the entire observation period (HR 1.34, 95% CI , p = 0.06).

12 JBR 10 trial n engl j med 352;25 june 23, 2005

13 JBR patients with completely resected stage IB or II (excluding T3N0) NSCLC. Randomly assigned to surgery followed by four cycles of vinorelbine (25 mg/m2 weekly for 16 weeks) plus cisplatin (50 mg/m2 days 1 and 8, every four weeks) or surgery alone. Five-year overall survival rate was significantly increased with adjuvant chemotherapy compared to observation (67 versus 56 percent, hazard ratio 0.78). Stage II disease had a significant improvement in five-year overall survival (59 versus 44 percent). Stage I NSCLC Overall, there was no benefit (five-year survival 76 versus 69 percent, HR 1.03). Primary tumor 4 cm, chemotherapy improved survival (79 versus 59 percent, HR 0.68). Findings regarding the impact of primary tumor size are consistent with the CALGB 9633 trial.

14 JBR 10

15 JBR 10

16 LACE- Adjuvant cisplatin trials

17 LACE - Summary Pooled analysis of 4584 patients. Median follow-up of 5.2 years. Adjuvant chemotherapy - decreased risk of death of 5.4 percent at five years compared to no chemotherapy (hazard ratio [HR] 0.89, 95% CI ). Survival benefit - most pronounced for patients with stage II and IIIA disease. Stage IB disease did not reach statistical significance, and patients with stage IA disease did worse with adjuvant chemotherapy: Stage IA HR 1.40 (95% CI ) Stage IB HR 0.93 (95% CI ) Stage II HR 0.83 (95% CI ) Stage III HR 0.83 (95% CI )

18 CALGB 9633 CALGB 9633 Cancer and Leukemia Group B (CALGB) the only large adjuvant chemotherapy trial utilizing carboplatin rather than cisplatin. 344 patients with completely resected stage IB NSCLC. Randomly assigned to four cycles of adjuvant paclitaxel (200 mg/m2 over three hours every three weeks) plus carboplatin (area under the concentration x time curve [AUC] 6 every three weeks) or observation. Preliminary report presented at the American Society of Clinical Oncology (ASCO) meeting in 2004 Significant improvements in overall and disease-free survival. Median follow-up of 34 months, adjuvant chemotherapy was associated with a 38 percent reduction in the risk of death (HR=0.62; 95%CI ). 12 percent improvement in four-year overall survival rate (71 versus 59 percent). Trial was stopped early. However, at median follow-up of 74 months Survival was no longer statistically significant (HR 0.83, 95% CI ) Subset analysis, there was a statistically significant survival advantage for patients whose tumors were greater than or equal to 4 cm (HR 0.69, 95% CI ).

19 Molecularly Targeted Agents No indication for the use of targeted agents as an adjuvant outside of a clinical trial setting. Multicenter phase II SELECT trial is studying adjuvant erlotinib 100 patients with resected, state IA to IIIA EGFR mutation positive NSCLC who have undergone adjuvant chemotherapy and/or radiation therapy. Preliminary results presented at 2014 ASCO meeting Improvement in disease-free survival compared with historical controls. Phase 3 study

20

21 Pre operative chemotherapy or chemoradiation Stage IIIA disease not initially resected. Not indicated for multiple mediastinal node involvement and bulky node (>3 cm). In some patients down staging may achieved for R0 resection Chemotherapy vs Chemoradiotherapy?

22 Chemotherapy vs Chemoradiotherapy Chemotherapy Lower cost Less morbidity (Radiation pneumonitis and esophagitis) Lower post operative mortality particularly if pneumonectomy is required. Chemoradiotherapy Higher rates of mediastinal downstaging Higher rates of pathologic Cr Higher rates of R0 resection

23 Current Clinical Trials

24 Current Clinical Trials

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