Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 7016
© 2004 American Society of Clinical Oncology

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Abstract

Vinorelbine (NVB)-carboplatin (CBDCA) vs non-platinum doublets in inoperable non-small cell lung cancer (NSCLC) patients (pts)-final results of the Glob 2 phase III with patient benefit analysis

Groote Schuur Hospital, Cape Town, South Africa; Mazowieckie Centrum Leczenia, Otwock, Poland; Helsinki University Central Hospital, Helsinki, Finland; Onkologie/Hämatologie Kantonsspital, Aarau, Switzerland; Masaryk Hospital, Usti nad Labem, Czech Republic; Westmead Hospital, Sydney, Australia; Hospital San Juan de Alicante, San Juan de Alicante, Spain; AOS Giovanni Battista Molinette, Torino, Italy; Krankenhaus Grosshandorf, Grosshandorf, Germany; National Cancer Centre, Singapore, Singapore

7016

Background: NVB-CDDP is used as a standard regimen for pts with NSCLC. Regimens in which CDDP is replaced by CBDCA or a non Platinum (P) cytotoxic, may result in more favourable tolerance and convenience This phase III was set up to compare a P based regimen (NVB-CBDCA) to a non-P based regimen (NVB-GEM). Methods: Inoperable NSCLC pts were randomly assigned to q3w cy in Arm A (A): NVB 30 mg/m2 at D1,8+CBDCA AUC 5 at D1 or Arm B (B): NVB 25 mg/m2+GEM 1000 mg/m2 both given at D1,8 with 150 evaluable pts planned in each arm. Objective response (OR) was the primary endpoint with secondary end points being time related parameters/tolerance and clinical benefit evaluated on 6 cancer symptoms evolution taking into account weight and PS changes. Results: 316 pts were recruited in 2 yrs in 31 centres with 159 pts in A and 157 in B. Groups were well balanced with same median age: 60/59y, KPS: 90–100 in 63/69%. In both arms pts were metastatic at inclusion in 80%. A median number of 4 cy was given. Median RDI for NVB was 91% (A) and 94% (B) with median RDI for CBDCA at 94% and GEM at 93%. OR in ITT after review was 20.8% (DC=66%) in A vs 28% (DC=72.6%) in B (p=0.15). At the cut-off date (April 1^st, 2003), median follow-up was 21.5 m with 128/110 deaths in A/B. MS was 8.6m for A vs 11.5m for B with 1 year survival respectively at 34.4% and 48.9% (p=0.01) and PFS at 3.9 and 4.4m. Main gr3–4 haematological AEs by pts in A/B, were: neutropenia in 44.5/23.4% and significantly more febrile neutropenia in A (17pts/19cy) vs B (1pt/1cy) with 4/0 toxic deaths respectively. There were less gr3–4 non-hematological tox reported in B. Regarding clinical benefit, fatigue, appetite, cough and dyspnea improvement were better in B. Chest pain and hemoptysis improvement were similar in both arms. Mean weight was stable in both. On 111 evaluable pts for the clinical benefit in A, response rate was 32.4% compared to 40.9% (p=0.19) in 110 evaluable pts in B. Conclusions: NVB-GEM given as a non-P doublet in this phase III has demonstrated OR, PFS and clinical benefit comparable to NVB–CBDCA doublet with a favorable MS and tolerance profile.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pierre Fabre

Abstract presentation from the 2004 ASCO Annual Meeting