1190P - Randomized phase II trial of S-1 plus cisplatin or docetaxel plus cisplatin with concurrent thoracic radiotherapy for inoperable stage III non-smal...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Cytotoxic agents
Surgical oncology
Non-small-cell lung cancer
Therapy
Biological therapy
Radiation oncology
Presenter Kazuhiko Yamada
Citation Annals of Oncology (2016) 27 (6): 411-415. 10.1093/annonc/mdw382
Authors K. Yamada1, T. Shimokawa2, H. Okamoto2, H. Tanaka2, K. Kubota2, K. Kishi2, H. Saitho2, Y. Takiguchi2, Y. Hosomi2, T. Kato2, D. Harada2, N. Masuda2, T. Kasai2, Y. Nakamura2, K. Minato2, T. Kaburagi2, K. Naoki2, K. Hikino2, T. Yamanaka2, K. Watanabe2
  • 1Division Of Respirology, Neurology, And Rheumatology, Department Of Internal Medicine, Kurume University, 830-0011 - Kurume/JP
  • 2Torg1018 Study Group, Thoracic Oncology Research Group, Yokohama/JP

Abstract

Background

Concurrent chemoradiotherapy (CCRT) is the current standard treatment for inoperable stage III non-small cell lung cancer (NSCLC), and a clearly superior regimen has not yet been identified. This study was conducted to evaluate cisplatin with S-1 (SP) or docetaxel (DP) with concurrent thoracic radiotherapy in patients with inoperable stage III NSCLC.

Methods

In this open-label, non-comparative phase II trial, patients with inoperable stage IIIA/B NSCLC were randomized (1:1) to SP (S-1 40 mg/m2 twice a day on days 1-14 and 29-42, and cisplatin 60 mg/m2 on days 1 and 29) or DP (docetaxel 50 mg/m2 and cisplatin 60 mg/m2 on days 1 and 29). In both arms, concurrent radiotherapy was started on day 1 (total 60 Gy in 30 fractions). After CCRT, patients in each group received two additional cycles of consolidation chemotherapy with the same regimen as that for the CCRT part. The primary endpoint was the 2-year overall survival (OS) rate,, and secondary endpoints were OS, progression-free survival (PFS), toxicity profile, dose intensity and objective response rate (ORR).

Results

Between May 2011 and August 2014, 110 patients from 19 institutions were enrolled. Finally, 106 patients (56 in each arm) were evaluable for efficacy and safety. The patient characteristics were: male/female, 83/23; median age, 65 (range 42-74) yr; ECOG performance status 0/1, 59/47; IIIA/IIIB, 59/47. After a median follow-up of 23.1 months, ORR and median PFS were 71.7% (95%CI: 57.7-83.2) and 11.5 months (95%: 9.00-14.1) in the SP arm, and 67.9% (95%CI: 53.7-80.1) and 17.2 months (95%: 9.62-24.0) in the DP arm, respectively. Grade 3-4 leukopenia (34.0%/62.3%) and neutropenia (28.3%/56.6%) were significantly higher in the DP arm than in the SP arm. Incidences of non-hematological toxicity including febrile neutropenia, anorexia, nausea, diarrhea, radiation pneumonitis and esophagitis tended to be high in the DP arm. No treatment-related death occurred.

Conclusions

At this preliminary stage, it appears that although the DP arm may have more toxic effects than the SP arm, it has a favorable PFS. The OS data will be available soon.

Clinical trial identification

UMIN000005993

Legal entity responsible for the study

Thoracic Oncology Research Group

Funding

Thoracic Oncology Research Group

Disclosure

T. Shimokawa, H. Okamoto: I have received research funding from Takeda, MSD, Ono, Astrazeneca, Merck, Chugai, Taiho, Bristol, Eli Lilly and Parexel. K. Kubota: Honoraria: Taiho, Chugai, Eli-Lilly.

Y. Takiguchi: Grants and lecture fees from Chugai, Bristol-Myers Squibb, Kyowa Hakko Kirin, Merck Serono, Boehringer Ingelheim Japan, Ono, Taiho, grants from Eli Lilly Japan, Mochida, lecture fees from AstraZeneca Japan, outside the submitted work. Y. Hosomi: Speaker Fees as honoraria from Chugai, Eli Lilly Japan, AstraZeneca, Taiho and Ono, outside the submitted work. T. Kato: Taiho pharmaceuticals: Lecture fee and research grant. T. Yamanaka: Honoraria: Taiho, Chugai, Takeda. All other authors have declared no conflicts of interest.