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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): C. Audigier-Valette
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endpoint was time to failure treatment (TTF=duration between the date of randomization and the date the patient was withdrawn from treatment for any reason (progression, toxicity, death), secondary endpoints were Overall Response Rate (ORR), overall survival (OS), toxicity and quality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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P3.10 - Poster Session 3 - Chemotherapy (ID 210)
- Event: WCLC 2013
- Type: Poster Session
- Track: Medical Oncology
- Presentations: 1
- Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
P3.10-041 - Impact of a Comprehensive Geriatric Assessment on management strategies in elderly patients with advanced no small cell lung cancer (NSCLC): a polled analysis of two phase 2 prospective study of the GFPC group. (ID 2418)
09:30 - 16:30 | Author(s): C. Audigier-Valette
The impact of a systematic use of a Comprehensive Geriatric Assessment (CGA) on management strategies in elderly patients with no small cell lung cancer (NSCLC) is not well established. The objective of this study was to analyze if items of CGA may predict overall survival of elderly patients with NSCLC treated by chemotherapy or erlotinib in first or second lines setting.
Individuals data’s of GFPC 0504 study (population of fit elderly patients) and GFPC 0505 study (population of frail elderly patients) were pooled. The aim of these two prospective phase 2 trials were to compare a strategy using chemotherapy (doublet in fit patients, monotherapy in frail patients) in first line followed by erlotinib in second line to the reverse strategy (erlotinib in first line, followed by chemotherapy), in terms of progression-free survival (PFS) in second line period. Secondary outcomes were to compare first-line PFS, overall survival (OS), tolerance and costs. All patients had a complete comprehensive geriatric assessment, evaluating diverse areas as functional status, nutritional status, cognition, psychological functioning, and social support, at randomization. Predictive factors associated with OS were searched using Kaplan-Meier curves and logrank tests in the univariate analysis. A Cox model was used for the multivariate analysis.
195 patients were included. Mean age was 77 years. 135 (70%) patients were males, 172 (89%) were stage IV and 109 (56%) were no or ex-smokers. At CGA assessment, 176 patients (70%) had an IADLD score of 3 or 4, 129 pts (66%) had a 0 or 1Charlson score, 167 pts (86%) had a simplified Charlson score < 8, 19 pts had a MMS score < 30, 146 pts (75%) had a situational score >10, 33 (17%) had a nutritional score <8. Factors predicting OS in the univariate analysis were 1-3 PS scores (1.5 [1.1 – 2.0], p=0.01); no or ex-smoker (0.70 [0.52–0.95], p = 0.02); 2-4 Charlson score (2.0 [1.4 – 2.7], p<0.0001, Simplified Charlson score ≥ 8 (1.50 [1.10–2.07],p=0.03), nutritional score>8 (0.60 [0.42 – 0.91], p= 0.01); 2 level mobility score (0.15 [0.04 – 0.62], p = 0.009). In the multivariate analysis, remained 1-3 PS (1.4 [1.02 – 1.9], p = 0.04), 2-4 Charlson score (1.46 [1.07 – 1.99], p=0.02), >8 nutritional score (0.69 [0.46 – 1.04], p= 0.07), level 2 mobility score level (0.25 [0.06 – 1.01], p = 0.06)
Comorbidities, nutritional and mobility scores, in this specific elderly population are predictive of OS. Prospective studies using large prospective cohort are needed to better select the more relevant management for elderly with advance NSCLC.