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

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

2 Global incidence, CA cancer J Clin 2011;61:69-90

3 Stage III NSCLC Includes heterogeneous group of patients with differences in the extent and localization of disease Approximately 27% of patients with NSCLC Goals of treatment are local control and eradication of micrometastatic disease

4 Surgical resection Recommended for patient with stage III N0 or N1 if complete resection is feasible T3N1 T4 N0/1 Except Pancoast tumor Adjuvant chemotherapy using platinum-based chemotherapy is considered following resection

5 stage IIIA (N2) Potentially resectable disease

6 Concurrent chemoradiotherapy ± surgery (Intergroup 0139) 429 potentially resectable NSCLC Stage IIIA-N2 45 Gy/25 fx RT Cisplatin/etoposide x 2 1:1 61 Gy RT Surgery Cisplatin/etoposide X2 Albain KS, Lancet. 2009;374(9687):379

7 Primary endpoint = OS Progression-free survival 5-y PFS: 22% 11% Overall survival 5-y OS : 27% CT/RT/S 20% CT/RT

8 Overall survival- lobectomy cohort Overall survival-pneumonectomy cohort 5 y OS: 36% 18% P= y OS: 22% CT/RT/S 24% CT/RT 26% postoperative mortality

9 van Meerbeeck, JP J Natl Cancer Inst. 2007;99(6):442 EORTC patients with stage IIIA-N2 NSCLC 3 cycles platinum doublet Responders (57%) 1: Gy RT (elective nodes Gy) N=165 Surgery n=167

10 Primary endpoint = OS PFS 9.0 vs mo p=0.605 OS 16.4 vs.17.5 mo

11 Unresectable stage III disease

12 % 5 yr OS % 5 yr OS Concurrent versus sequential chemoradiotherapy WJLCG RTOG pts MVP x2 Cont RT day 50 MVP x2/split RT day pts Vb/C X2 Stn RT day 50 Vb/C X2/Stn RT day % P=.039 sequential 19% concurrent PE x2/ BID RT day 1 P= % 10% sequential concurrent MVP- Mitomycin,cisplatin,vindesine Vb/C-Vinblastin,cisplatin PE-Cisplatin,etoposide Furuse K, J Clin Oncol. 1999;17(9):2692. Curran WJ Jr, J Natl Cancer Inst. 2011;103(19):1452

13

14 Chemotherapy regimen Trial Schedule Treatment N Med OS HOG cyclic Cisplatin/etoposide +RT RTOG 0617 weekly Carboplatin/paclitaxel +RT consolidation Cyclic Cisplatin+Etoposide for 2cycles Weekly Carboplatin+paclitaxel followed by full dose carboplatin+paclitaxel for 2 cycles Are acceptable regimens with concurrent RT Regimens including Gemcitabine were associated with increased incidence of pulmonary toxicity Platinum-pemetrexed regimen has showed promising safety and efficacy

15 Strategies for the treatment of unresectable stage III NSCLC CONCURRENT CHEMORADIOTHERAPY Induction chemotherapy Consolidation chemotherapy Targeted therapy

16 The role of induction chemotherapy CALGB Stage III 366 patients 2 yr OS 29% 31% Paclitaxel 50 mg/m2 Carboplatin AUC 2 XRT 66 Gy (total) Paclitaxel 200 mg/m2 Carboplatin AUC 6 x2 cycles P=0.3 Paclitaxel 50 mg/m2 Carboplatin AUC 2 XRT 66 Gy (total) Vokes EE, J Clin Oncol. 2007;25(13):1698

17 The role of consolidation chemotherapy HOG LUN chemort Cisplatin 50mg/m2 IV d 1,8,29,36 Etoposide 50mg/m2 IV d 1-5 & Concurrent RT 59.4Gy (1.8 Gy/fr) N=203 Randomize N=147 Median: 21.2 months 3 y survival rate: 27.1% Median: 23.2 months 3 y survival rate: 26.1 P=0.883 Docetaxel 75mg/m2 Q 3 wk x3 N=73 Observation N=74 Hanna N, J Clin Oncol. 2008;26(35):5755

18 The role of maintenance therapy SWOG 0023 R Definitive TX consolidation maintenance A Cisplatin 50mg/m2 N placebo D 1,8,29,36 Etopside 50mg/m2 Docetaxel D D 1-5, mg/m2 O XRT 61Gy X 3cycles M Gefitinib 1.8-2Gy/d I Z E Kelly K, J Clin Oncol. 2008;26(15):2450

19 Randomization RTOG 0617: Integration of Targeted Agent in Combined Modality Therapy Chemo XRT (60Gy) chemotherapy Stage III NSCLC N=544 Chemo XRT (60Gy)+ Cetuximab Chemo XRT (74Gy) Chemotherapy Cetuximab chemotherapy Chemo XRT (74Gy)+ cetuximab Chemotherapy Cetuximab No improvement in survival with addition of cetuximab compared with chemotherapy alone (med OS 23.1 versus 23.5 months) Overall survival was better with standard dose of RT( med OS 28.7 versus 19.5 months; p<0.001) Chemotherapy: Paclitaxel+carboplatin Bradley J, IASLC 15th World Conference on Lung Cancer, 2013

20 RTOG 1210/Alliance A randomized phase II trial Stage III NSCLC With either EGFR Mutation Or ALK fusion Experimental Control EGFR mutation + Erlotinib 3months followed by chemort * ALK fusion+ Crizotinib 3months followed by chemort * EGFR Mutation +/ALK fusion + chemort * only *Chemotherapy: weekly paclitaxel+carboplatin followed by 2cycles of consolidation pac/cp cyclic Etoposide+Cisplatin X2cycles N=234 Primary endpoint: progression free survival

21 Concurrent Chemoradiotherapy and Molecularly Targeted Agents Phase Phase III Trial Tecemotide following concurrent chemoradiotherapy in NSCLC (START2) Phase II Afatinib CT (pemetrexed/cisplatin) and RT for EGFR mutant NSCLC Phase I Trametinib with CT (paclitaxel/carboplatin) and RT in KRAS mutant NSCLC Phase I Veliparib plus Paclitaxel/carboplatin and RT in NSCLC (S1206)

22 10.8m 14 m 17 m 28.7m

23 Conclusion Concurrent chemoradiotherapy with platinum-based is recommended for patients with stage IIIA(N2) or unresectable stage III NSCLC and good performance status The role of surgery following concurrent chemoradiotherapy remains unproven. Surgery may be appropriate if tumor can be resected by lobectomy rather than pneumonectomy No demonstrated survival advantage for induction chemotherapy or consolidation chemotherapy Targeted therapy is not indicated outside of clinical trial for patient with stage III NSCLC

24 Thanks

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