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O15 - NSCLC - Chemotherapy II (ID 109)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:G. Richardson, J.V. Heymach
- Coordinates: 10/29/2013, 10:30 - 12:00, Bayside Auditorium A, Level 1
O15.03 - Phase III, randomized, multicenter study comparing in elderly patients (≥70 years) with stage IV non small-cell lung cancer (NSCLC) a standard strategy of treatment allocation (carboplatin based bi-therapy or monotherapy with docetaxel) based on performance status (PS) and age with an experimental strategy allocating the same chemotherapies or best supportive care (BSC) according to a comprehensive geriatric assessment (CGA) - Study ESOGIA-GFPC-GECP 08-02. (ID 694)
10:30 - 12:00 | Author(s): S. Bota
Incidence of advanced NSCLC in the elderly is increasing. The use of a CGA is recommended to detect the patient’s vulnerability but its integration in treatment decision making has never been prospectively evaluated. The main objective of this study was to show that, compared to a standard strategy based on PS and age, the use of a CGA can improve the management of NSCLC in first line.
Randomized, multicentric, prospective phase III study in patients ≥70 y, PS 0-2 with stage IV NSCLC. We compared in arm A a standard algorithm of chemotherapy allocation based on PS and age: carboplatin based doublet in PS≤1 and age ≤75y, mono-therapy in PS =2 or age >75y with in arm B an experimental strategy of treatment allocation based on CGA: carboplatin based doublet for fit patients, mono-therapy for vulnerable patients and BSC for frail patients. Carboplatin (AUC5,d1), was associated to pemetrexed (500 mg/m2,d1) in non-squamous tumors and to gemcitabine (1000 mg/m2, d1-8) in squamous tumors, monotherapy was docetaxel 38 mg/m2 (d1-8). Four cycles of chemotherapy were to be given every three weeks. The main endpoint was time to failure treatment (TTF=duration between the date of randomization and the date the patient was withdrawn from treatment for any reason (progression, toxicity, death), secondary endpoints were Overall Response Rate (ORR), overall survival (OS), toxicity and quality of life (QoL), survival adjusted on QoL .
493 patients were randomized from 01/2010 to 01/2013 by 45 centers. Patients characteristics were: male: 74%, median age: 77 (70-91) years, non-squamous histology: 71.8%, PS 0-1: 81.4%, ADL<6:13.9%, IADL<4:27.5%, Charlson’s index ≥2: 23%, score GDS 5≥3:2.5%. The 2 arms were well-balanced for patients characteristics except for ADL<6 (17.4% in arm A vs 10.3% in arm B). Respectively in arms A and B, 34.4% and 47% patients received a carboplatin based doublet, 65.6% and 31.5% received docetaxel and in arm B 21.5% received BSC. There was no significant difference in terms of TTF, respectively for arm A and arm B: median TTF was 99 days (d), 95%CI:[89; 126] vs. 98 d, 95%CI:[81;135], p=0.7149 and in terms of mOS: 196 d in arm A, 95%CI [171;231] vs. 185 d in arm B ,95%CI [148;235], p=0.7784. All grades toxicities were significantly less frequent in arm B than in arm A (93% vs.86.2%, p=0.016), but there was no difference in terms of grade 3-4 toxicities. All the secondary endpoints data will be updated at time of the meeting.
this large phase III study failed to show a superiority of a CGA based strategy of treatment allocation in terms of TTF. In experimental arm, 21.5% of frail patients according to Balducci’s criteria were enrolled and received an exclusive BSC management. Carboplatin-based doublets with pemetrexed and gemcitabine according to histology are feasible with a good profile of tolerance in selected elderly patients. This study will help to precise the most relevant geriatric tools and their cut-off in order to improve the management of the elderly with advanced NSCLC.
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P2.10 - Poster Session 2 - Chemotherapy (ID 207)
- Event: WCLC 2013
- Type: Poster Session
- Track: Medical Oncology
- Presentations: 1
- Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
P2.10-013 - Randomized non comparative multicenter phase II study of sequential erlotinib with docetaxel versus docetaxel alone in patients with non small cell lung cancer (NSCLC) after failure of first line chemotherapy (TARSEQ): a GFPC 10.02 study. (ID 972)
09:30 - 16:30 | Author(s): S. Bota
Erlotinib and docetaxel are approved in second line treatment of advanced NSCLC. Concomitant administration of a tyrosine kinase inhibitor (TKi) of EGFR with standard chemotherapy in first line did not improve survival compared to chemotherapy alone. Preliminary studies support a possible efficacy of sequential administration of EGFR TKi and chemotherapy. Objective: This open randomized phase II trial (Tarseq) was designed to assess the efficacy and tolerability of second-line sequential erlotinib plus docetaxel in advanced NSCLC.
Patients were randomized (1/1, stratified by center, disease status: recurrent or refractory (no response observed after 4 cycles of first-line chemotherapy))between sequential erlotinib 150 mg/d (day 2-16) + docetaxel (75 mg /m2 d1- 21) (arm A) versus docetaxel (75mg/m2 d1) alone (arm B) until disease progression or unacceptable toxicity. Primary endpoint was the rate of patients with progression-free survival at 15 weeks (PFS15) ; second endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and tolerability. Main eligibility criteria were advanced NSCLC, EGFR wild type or unknown, performance status 0 to 2, failure of first line cisplatin based chemotherapy; main exclusion criteria were more than 2 lines of treatment, previous anti-EGFR or docetaxel treatment. Statistical analysis was based on a Simon’s optimal two stage design . The primary endpoint is rejected if the number of efficacy is less 33 over 66 pts (25+ 41) at the end of the two stages.
147 patients were randomized by 33 centers: median age: 60 ± 8 years, PS 0/1/2 (44/83/20 pts) ; male: 78%, EGFR status: wild type 66%, unknown: 34%; recurrent patients: 65% (arms A/B :66%/65%), nonsquamous: 86% (arms A/B : 84%/90%), smoking status: smokers 35%, formers 57,5%, never 7,5%. Baseline characteristics were balanced between 2 arms. In ITT, the primary objective was not meet with 18/66 pts without progression at 15 weeks in arm A, 17 /66 pts in arm B. In arm A and B, median PFS was 2,2 (CI95% 1,6-2,8) and 2,5 (CI 95% 1,7-2,8) months and median OS was 6,6 (CI 95% 4,3-10,3) and 8,4 (CI 95% 4,5-11,3) months respectively. Toxicity was acceptable in both arms with 60.2 % and 54% of G3/4 toxicity in arms A and B, respectively.
The sequential combination of erlotinib with docetaxel did not demonstrate any benefit in second-line treatment of EGFR wild type or unknown advanced NSCLC, despite acceptable toxicity. The Pharmacological hypothesis of synergism between erlotinib given sequentially and standard chemotherapy is not confirmed in the present study. Clinical trial information: NCT01350817 / Supported by an academic grant from Roche, Chugai, Sanofi Aventis,with the help of clinical research direction ( Limoges University Hospital)