Heather Wakelee, M.D.
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1 Heather Wakelee, M.D. Assistant Professor of Medicine, Oncology Stanford University Sponsored by Educational Grant Support from Adjuvant (Post-Operative) Lung Cancer Chemotherapy Heather Wakelee, M.D. Assistant Professor of Medicine, Oncology Stanford University 1
2 TNM Staging of NSCLC T: Tumor size and invasion N: Lymph Nodes M: Metastases Stage I T1/T2 N M Stage II T1/2 N1 M Stage IIIA T1-3 T3 N2 N1 M *T indicates primary tumor; N, nodal involvement ; M, distant metastasis. AJCC Cancer Staging Manual. 5th ed. Philadelphia, Pa: Lippincott-Raven; 1997: Stage I/II NSCLC: Overview Stage I Surgical resection: cure 6-8% Controversy about adjuvant (postoperative) chemotherapy Stage II Surgical resection: cure 5-7% Post-operative (Adjuvant) chemotherapy improves cure rates 5-15% 2
3 1995 Meta-Analysis Adjuvant Cisplatin Trials (1394 patients) Percentage Survival Surgery plus Chemotherapy Surgery HR.87 p=.8 Brit Med J 31: , Time from Randomization (months) 5% absolute survival benefit at 5 years, (non-significant) Lung Adjuvant Cisplatin Evaluation (LACE) 5 trials - 4,584 patients Median follow-up: 5.1 years OS HR.89 [ ], p=.5 Stage IA HR 1.4 [.95, 2.6] Stage IB HR.93 [.78, 1.1] Stage II/III HR.83 [.73,.95] 5 % improvement in cure at 5 years Pignon J Clin Oncol 26:3552, 28 3
4 Updated Overall Survival by Treatment Arm - JBR.1 >9yr f/up ' 1 8 Fig.1 All Patients Observation Stratified Log-Rank: p=.4 HR:.78(.613,.993) Chemo Vinorelbine Percentage yr: 67% vs 56% MST 94m vs 72m At Risk Observation Vinorelbine Time(Years) Absolute improvement in 5 yr overall survival 11% All benefit in Stage II Stage IB Analysis: CALGB 9633 Trial T < 4 cm T 4 cm CALGB 9633 HR OS p HR OS p JBR No Chemo Benefit Potential Chemo Benefit Strauss, J Clin Oncol 28 4
5 The Future of Adjuvant Therapy for Early Stage NSCLC Prognostic vs. Predictive Markers Prognostic Marker Indicates survival benefit/detriment regardless of therapy Stage, tumor size, sex Predictive Marker Predicts for differential benefit from a particular therapy Varlotto,Cancer 29 5
6 IALT: Prognostic and Predictive Value of ERCC1 in Adjuvant Treatment of NSCLC Patients With ERCC1-Negative Tumors Patients With ERCC1-Positive Tumors Overall survival (%) Chemotherapy (15 deaths) 4 Control (113 deaths) 2 HR =.65 (.5-.86) P= Overall survival (%) Control (8 deaths) 4 Chemotherapy (92 deaths) 2 HR = 1.14 ( ) P= Years Years 28:HR.76 [ ] 28:HR 1.2 [ ] Olaussen KA. NEJM ;355:983, 26 Predictive Markers in NSCLC To date, these prognostic + predictive factors in early stage are based on RETROSPECTIVE analyses PREDICTIVE markers in advanced NSCLC In general low levels = sensitivity ERCC1 - platinum Thymidylate Synthase (TS) - pemetrexed RRM1 - Gemcitabine BRCA 1 - low platinum, but HIGH for taxanes EGFR mutation - EGFR-TKIs 6
7 Prospective Biomarker Adjuvant Therapy Trials Stage Therapy Marker C356 Stage I +/- Chemotherapy Metagene SWOG 72 Stage I +/- Chemotherapy (Cis/Gem) ERCC1 /RRM1 ITACA Stage I-IIIA Cisplatin/Pemetrexed ERCC1/TS TASTE Stage I-IIIA Cisplatin / Erlotinib ERCC1/ EGFR mut SCAT Stage I-IIIA Platinum / Docetaxel BRCA1/ RAP8 Targeted Agents Lung Cancer is heterogeneous No magic bullet is likely Chemotherapy targets DNA replication Multiple other cellular targets EGFR inhibitors - Epidermal Growth Factor Receptor VEGF inhibitors - Vascular Endothelial Growth Factor Vaccines 7
8 EGFR Signaling: Survival, Proliferation, Angiogenesis EGFR Adaptor proteins Nucleus PLC P P GRB2 Gene activation Cell cycle progression M G 1 MYC FOS G 2 S JUN Signaling cascades Proliferation Survival Angiogenesis Harari and Huang. Clin Cancer Res. 2;6:323; Herbst. Int J Radiat Oncol Biol Phys. 24;59(suppl):21. EGFR: Targeted Approaches Tarceva (erlotinib) Iressa (gefitinib) Anti-receptor blocking antibodies Adapted from Noonberg and Benz. Drugs. 2;59:753. Tyrosine kinase inhibitors Antiligand blocking antibodies 8
9 Erlotinib-EGFR inhibitor Phase III data BR.21: 2nd or 3rd line Adv NSCLC Endpoint Erlotinib Placebo (n=427) (n=211) Response 9% <1% Survival (mo) year survival 31% 22% * p<.1 **p=.4,.1,.2 for cough, dyspnea, pain respectively Shepherd, ASCO 23:722, 24, NEJM 25 RADIANT Adjuvant NSCLC +/- Tarceva (Erlotinib) ELIGIBLE: N=945 Resected I-IIIA Chemo optional R A N D O M I Z E 2:1 Tarceva (Erlotinib) 15 mg by mouth daily x 2 yrs Placebo x 2 years Disease-Free Survival as primary endpoint 9
10 The Angiogenic Switch VEGF critical for the pathway Angiogenic 1-2 mm Switch Small tumor Nonvascular Dormant Larger tumor Vascular Metastatic potential VEGF: Targeted Approaches Avastin (Bevacizumab) Anti-receptor blocking antibodies Adapted from Noonberg and Benz. Drugs. 2;59:753. Tyrosine kinase inhibitors Antiligand blocking antibodies 1
11 E4599: Survival with Chemo +/- Avastin (Bevacizumab) for Advanced NSCLC Probability patients PC PCB HR:.77 (.65,.93) P =.7 Medians: 1.3, 12.3 mo 12 mo. 24 mo. 44% 17% 52% 22% Months Sandler ASCO 23:LBA 4, 25 Avastin (Bevacizumab) in Adjuvant Therapy for Resected NSCLC: Rationale for E155 Benefit of adjuvant chemotherapy for resected NSCLC clearly established Benefit of VEGF inhibition proven in adv NSCLC 2 month survival benefit with bevacizumab added to chemotherapy for stage IV NSCLC Next logical step: study anti-angiogenesis with bevacizumab in the adjuvant setting Optimal chemotherapy not established, so 4 chemotherapy options Controversy over stage IB benefit - limited to those with tumors at least 4 cm in size 11
12 ECOG 155 : Chemo+/- Avastin Bevacizumab As Adjuvant Therapy for Resected NSCLC ELIGIBLE: Resected IB-IIIA R A N D O M I Z E Chemotherapy X 4 cycles Chemotherapy x 4 cycles + Avastin (Bevacizumab) x 1 year * Investigator choice of 4 chemo regimens Adjuvant Vaccine Trials: MAGE A3 MAGE-A3 - cancer specific tumor antigen 35-5% of lung cancer Give purified recombinant protein and immunologic adjuvant together (GSK A) Phase II trial showed minimal toxicity (mostly local reaction) Promising randomized phase II results 12
13 MAGRIT Adjuvant NSCLC (+/-Chemo)+/- MAGE-A3 Vaccine ELIGIBLE: N=227 screened Resected IB-IIIA Required MAGE-A3 Expression (<4%) Chemo optional R A N D O M I Z E MAGE-A3 vaccine x 13 injections over 27 mo Placebo injections on same schedule Disease-Free Survival as primary endpoint Conclusions Adjuvant cisplatin chemotherapy is now standard of care for pts with resected stage II/IIIA NSCLC Long term follow-up important Critical issues are: Better patient selection (ERCC1, gene analysis, etc.) Better drugs are needed (targeted) EGFR, VEGF, VACCINES 13
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