Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-disease smallcell lung cancer (LD-SCLC): TORG 0604

Yuki Misumi, Hiroaki Okamoto, Jiichiro Sasaki, Noriyuki Masuda, Mari Ishii, Tsuneo Shimokawa, Yukio Hosomi, Yusuke Okuma, Makoto Nagamata, Takashi Ogura, Terufumi Kato, Masafumi Sata, Sakiko Otani, Akira Takakura, Koichi Minato, Yosuke Miura, Takuma Yokoyama, Saori Takata, Katsuhiko Naoki, Koshiro Watanabe

Research output: Contribution to journalArticle

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Abstract

Background: The role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated. Methods: Patients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objective of the phase II study was overall responce rate. Results: Forty-three patients were enrolled and forty-one were finally analyzed (median age: 75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. Two patients were excluded because of protocol violation (ascertained to be extensive disease). Twelve patients were accrued at phase I and the number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and -2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose, total of 35 patients. The median number of chemotherapy cycles was 4 (range 1-4), and the median radiation dose was 54Gy (range 36-60). Toxicities were generally mild. There were 4 complete and 27 partial responses (response rate 88.6%). With a median follow-up of 52 months, the median progression-free and overall survival times of phase II were 11.2 and 27.1 months, respectively. Conclusions: Induction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted. Trial registration: Trial registration number: UMIN000007352. Name of registry: UMIN. Date of registration: 1/Dec/2006. Date of enrolment of the first participant to the trial: 6/Feb/2007. Clinical trial registration date: 1/Feb/2006 (prospective).

Original languageEnglish
Article number377
JournalBMC Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - 2017

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irinotecan
Induction Chemotherapy
Carboplatin
Lung Neoplasms
Radiotherapy
Thorax
Drug Therapy

Keywords

  • Carboplatin
  • Elderly
  • Irinotecan
  • LD-SCLC
  • Phase I
  • Phase II
  • Sequential radiotherapy

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-disease smallcell lung cancer (LD-SCLC) : TORG 0604. / Misumi, Yuki; Okamoto, Hiroaki; Sasaki, Jiichiro; Masuda, Noriyuki; Ishii, Mari; Shimokawa, Tsuneo; Hosomi, Yukio; Okuma, Yusuke; Nagamata, Makoto; Ogura, Takashi; Kato, Terufumi; Sata, Masafumi; Otani, Sakiko; Takakura, Akira; Minato, Koichi; Miura, Yosuke; Yokoyama, Takuma; Takata, Saori; Naoki, Katsuhiko; Watanabe, Koshiro.

In: BMC Cancer, Vol. 17, No. 1, 377, 2017.

Research output: Contribution to journalArticle

Misumi, Y, Okamoto, H, Sasaki, J, Masuda, N, Ishii, M, Shimokawa, T, Hosomi, Y, Okuma, Y, Nagamata, M, Ogura, T, Kato, T, Sata, M, Otani, S, Takakura, A, Minato, K, Miura, Y, Yokoyama, T, Takata, S, Naoki, K & Watanabe, K 2017, 'Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-disease smallcell lung cancer (LD-SCLC): TORG 0604', BMC Cancer, vol. 17, no. 1, 377. https://doi.org/10.1186/s12885-017-3353-y
Misumi, Yuki ; Okamoto, Hiroaki ; Sasaki, Jiichiro ; Masuda, Noriyuki ; Ishii, Mari ; Shimokawa, Tsuneo ; Hosomi, Yukio ; Okuma, Yusuke ; Nagamata, Makoto ; Ogura, Takashi ; Kato, Terufumi ; Sata, Masafumi ; Otani, Sakiko ; Takakura, Akira ; Minato, Koichi ; Miura, Yosuke ; Yokoyama, Takuma ; Takata, Saori ; Naoki, Katsuhiko ; Watanabe, Koshiro. / Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-disease smallcell lung cancer (LD-SCLC) : TORG 0604. In: BMC Cancer. 2017 ; Vol. 17, No. 1.
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abstract = "Background: The role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated. Methods: Patients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objective of the phase II study was overall responce rate. Results: Forty-three patients were enrolled and forty-one were finally analyzed (median age: 75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. Two patients were excluded because of protocol violation (ascertained to be extensive disease). Twelve patients were accrued at phase I and the number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and -2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose, total of 35 patients. The median number of chemotherapy cycles was 4 (range 1-4), and the median radiation dose was 54Gy (range 36-60). Toxicities were generally mild. There were 4 complete and 27 partial responses (response rate 88.6{\%}). With a median follow-up of 52 months, the median progression-free and overall survival times of phase II were 11.2 and 27.1 months, respectively. Conclusions: Induction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted. Trial registration: Trial registration number: UMIN000007352. Name of registry: UMIN. Date of registration: 1/Dec/2006. Date of enrolment of the first participant to the trial: 6/Feb/2007. Clinical trial registration date: 1/Feb/2006 (prospective).",
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author = "Yuki Misumi and Hiroaki Okamoto and Jiichiro Sasaki and Noriyuki Masuda and Mari Ishii and Tsuneo Shimokawa and Yukio Hosomi and Yusuke Okuma and Makoto Nagamata and Takashi Ogura and Terufumi Kato and Masafumi Sata and Sakiko Otani and Akira Takakura and Koichi Minato and Yosuke Miura and Takuma Yokoyama and Saori Takata and Katsuhiko Naoki and Koshiro Watanabe",
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volume = "17",
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TY - JOUR

T1 - Phase I/II study of induction chemotherapy using carboplatin plus irinotecan and sequential thoracic radiotherapy (TRT) for elderly patients with limited-disease smallcell lung cancer (LD-SCLC)

T2 - TORG 0604

AU - Misumi, Yuki

AU - Okamoto, Hiroaki

AU - Sasaki, Jiichiro

AU - Masuda, Noriyuki

AU - Ishii, Mari

AU - Shimokawa, Tsuneo

AU - Hosomi, Yukio

AU - Okuma, Yusuke

AU - Nagamata, Makoto

AU - Ogura, Takashi

AU - Kato, Terufumi

AU - Sata, Masafumi

AU - Otani, Sakiko

AU - Takakura, Akira

AU - Minato, Koichi

AU - Miura, Yosuke

AU - Yokoyama, Takuma

AU - Takata, Saori

AU - Naoki, Katsuhiko

AU - Watanabe, Koshiro

PY - 2017

Y1 - 2017

N2 - Background: The role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated. Methods: Patients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objective of the phase II study was overall responce rate. Results: Forty-three patients were enrolled and forty-one were finally analyzed (median age: 75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. Two patients were excluded because of protocol violation (ascertained to be extensive disease). Twelve patients were accrued at phase I and the number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and -2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose, total of 35 patients. The median number of chemotherapy cycles was 4 (range 1-4), and the median radiation dose was 54Gy (range 36-60). Toxicities were generally mild. There were 4 complete and 27 partial responses (response rate 88.6%). With a median follow-up of 52 months, the median progression-free and overall survival times of phase II were 11.2 and 27.1 months, respectively. Conclusions: Induction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted. Trial registration: Trial registration number: UMIN000007352. Name of registry: UMIN. Date of registration: 1/Dec/2006. Date of enrolment of the first participant to the trial: 6/Feb/2007. Clinical trial registration date: 1/Feb/2006 (prospective).

AB - Background: The role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated. Methods: Patients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0-2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objective of the phase II study was overall responce rate. Results: Forty-three patients were enrolled and forty-one were finally analyzed (median age: 75 years [range 70-86 years); males 31; PS 0/1/2, n = 22/18/1]. Two patients were excluded because of protocol violation (ascertained to be extensive disease). Twelve patients were accrued at phase I and the number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and -2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose, total of 35 patients. The median number of chemotherapy cycles was 4 (range 1-4), and the median radiation dose was 54Gy (range 36-60). Toxicities were generally mild. There were 4 complete and 27 partial responses (response rate 88.6%). With a median follow-up of 52 months, the median progression-free and overall survival times of phase II were 11.2 and 27.1 months, respectively. Conclusions: Induction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted. Trial registration: Trial registration number: UMIN000007352. Name of registry: UMIN. Date of registration: 1/Dec/2006. Date of enrolment of the first participant to the trial: 6/Feb/2007. Clinical trial registration date: 1/Feb/2006 (prospective).

KW - Carboplatin

KW - Elderly

KW - Irinotecan

KW - LD-SCLC

KW - Phase I

KW - Phase II

KW - Sequential radiotherapy

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U2 - 10.1186/s12885-017-3353-y

DO - 10.1186/s12885-017-3353-y

M3 - Article

AN - SCOPUS:85020231011

VL - 17

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

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M1 - 377

ER -