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Lung Cancer. 2017 Jun;108:232-237. doi: 10.1016/j.lungcan.2017.04.002. Epub 2017 Apr 4.

Randomized phase II trial of weekly dose-intensive chemotherapy or amrubicin plus cisplatin chemotherapy following induction chemoradiotherapy for limited-disease small cell lung cancer (JCOG1011).

Author information

1
Department of Medical Oncology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: isekine@md.tsukuba.ac.jp.
2
Radiotherapy Division, Shizuoka Cancer Center, Shizuoka, Japan.
3
Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
4
Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo Japan.
5
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
6
Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
7
Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
8
Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
9
Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
10
Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
11
Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
12
Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.
13
Department of Radiology, Koshigaya Municipal Hospital, Koshigaya, Japan.

Abstract

OBJECTIVES:

The objective of this study was to select, for a phase III trial, the more promising of weekly-dose intensive chemotherapy or amrubicin+cisplatin chemotherapy as subsequent therapy after induction chemoradiotherapy for previously untreated limited-disease small cell lung cancer (LD-SCLC).

MATERIALS AND METHODS:

Patients aged 20-70 years with untreated clinical stage II/III LD-SCLC were eligible. After one cycle of accelerated hyperfractionation thoracic radiotherapy with etoposide plus cisplatin, patients without progression were randomized to either 3 cycles of cisplatin 25mg/m2 (days 1, 8), doxorubicin 40mg/m2 (day 1), etoposide 80mg/m2 (days 1-3), and vincristine 1mg/m2 (day 8) every 2 weeks (CODE) or amrubicin 40mg/m2 (days 1-3) and cisplatin 60mg/m2 (day 1) every 3 weeks (AP). The primary endpoint was the one-year progression-free survival (PFS). The sample size was 72 to select the arm yielding a better one-year PFS (55% vs. 65%) with a probability of 80%.

RESULTS:

From March 2011 to February 2014, 85 patients were registered. After the induction chemoradiotherapy, 75 patients were randomized to CODE (n=39) or AP (n=36). The one-year PFS (95% confidence interval) was 41.0% (25.7-55.8) in the CODE group and 54.3% (36.6-69.0) in the AP group. Grade 4 neutropenia/grade 3 febrile neutropenia occurred in 47%/16% in the CODE group and 78%/42% in the AP group.

CONCLUSION:

The one-year PFS was better in the AP group, but it did not reach the expected 55%. Therefore, neither regimen is suitable for a phase III trial.

KEYWORDS:

Cisplatin; Limited disease; Small cell lung cancer; Weekly chemotherapy; amrubicin

PMID:
28625642
DOI:
10.1016/j.lungcan.2017.04.002
[Indexed for MEDLINE]

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