1190P - A randomized Phase II trial of cisplatin plus gemcitabine versus carboplatin plus gemcitabine in patients with completely resected non-small cell l...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Early Stage
Presenter Toshiyuki Harada
Citation Annals of Oncology (2014) 25 (suppl_4): iv409-iv416. 10.1093/annonc/mdu347
Authors T. Harada1, S. Fukumoto2, M. Harada2, K. Nakano2, N. Sukoh2, S. Fuke3, H. Asahina4, K. Takamura5, M. Yamamoto5, Y. Fujita6, K. Akie7, I. Kinoshita8, S. Oizumi4, H. Akita8, H. Isobe9, M. Nishimura4
  • 1Center For Respiratory Diseases, JCHO Hokkaido Hospital, 062-8618 - Sapporo/JP
  • 2Department Of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center, 0030804 - Sapporo/JP
  • 3Department Of Pulmonary Disease, KKR Sapporo Medical Center, 0620931 - Sapporo/JP
  • 4First Department Of Medicine, Hokkaido University School of Medicine, 060-8638 - Sapporo/JP
  • 5First Department Of Medicine, Hokkaido P.W.F.A.C Obihiro-Kosei General Hospital, 0800016 - Obihiro/JP
  • 6Department Of Pulmonary Disease, National Hospital Organization Asahikawa Medical Center, 0708644 - Asahikawa/JP
  • 7Department Of Pulmonary Disease, Sapporo City General Hospital, 0608604 - Sapporo/JP
  • 8Department Of Medical Oncology, Hokkaido University Graduate School of Medicine, 0608638 - Sapporo/JP
  • 9Clinical Oncology, KKR Sapporo Medical Center, 062-0931 - Sapporo/JP

Abstract

Aim

The combination of platinum and gemcitabine (GEM) (P/G) is one of the most beneficial regimens in advanced non-small cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of P/G in adjuvant chemotherapy of postoperative NSCLC and select the P/G arm for a phase III trial.

Methods

Patients with postoperative stage IB-IIIA NSCLC were randomly assigned to either cisplatin (CDDP) 40 mg/m2 on days 1 and 8 plus GEM 1000 mg/m2 on days 1 and 8 (GP arm) or carboplatin (CBDCA) AUC 5 on day 8 plus GEM 1000 mg/m2 on days 1 and 8 (GC arm) every 3 weeks for 4 cycles. The primary endpoint was 2-year disease-free survival (DFS); secondary endpoints were safety, feasibility, overall survival (OS), and biomarker analyses.

Results

102 patients were randomized (stages: 22% IB, 36% II, 42% IIIA; histology: 74% adenocarcinoma, 26% non-adenocarcinoma). Thirty-seven (73%) of 51 patients in each arm completed 4 cycles. Compliance was greater with GP than GC (dose intensity 87.6% vs. 77.9%, respectively; P < .005). Hematological toxic effects were comparable: grade ≥3 neutropenia was 69% (GP) and 76% (GC) (P =.37), and grade ≥3 thrombocytopenia was 33% (GP) and 43% (GC) (P =.31). Nonhematological toxic effects were infrequent. There was one (2%) treatment-related death in each arm. After a median follow-up of 37 (1-73) months, the estimated DFS and OS at 2 years were 59.6% and 86.1% with GP and 67.9% and 86.1% with GC, respectively. The estimated DFS rates with GP and GC were 52.6% and 65.5% at 3 years, and 43.3% and 65.5% at 4 years, respectively. No significant difference in DFS was noted between the arms (P =.14), although 3 and 4-year DFS rates were higher with GC.

Conclusions

Both P/G combination regimens were feasible and well-tolerated and, thus, may be potential options for adjuvant treatment in postoperative NSCLC. Although there were no significant differences in DFS between the two regimens, the data presented favor adopting GC for further evaluation.

Disclosure

All authors have declared no conflicts of interest.