A Phase II study of S-1 and irinotecan combination therapy in previously treated patients with advanced non-small cell lung cancer

Shinnosuke Ikemura, Katsuhiko Naoki, Hiroyuki Yasuda, Ichiro Kawada, Satoshi Yoda, Hideki Terai, Takashi Sato, Kota Ishioka, Daisuke Arai, Keiko Ohgino, Hirofumi Kamata, Jun Miyata, Hiroki Kabata, Tomoko Betsuyaku, Kenzo Soejima

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Abstract

Objective: This Phase II studywas conducted to evaluate the efficacy and safety of S-1 and irinotecan combination therapy as a second-line treatment in patients with advanced non-small cell lung cancer. Methods: Irinotecan was administered at 60 mg/m<sup>2</sup> on Days 1 and 8. Oral S-1 was administered on Days 1-14 every 3 weeks at 80 mg/day for patients with a body surface area of <1.25 m<sup>2</sup>, 100 mg/day for patients with a body surface area of 1.25-1.5 m2 and 120 mg/day for patients with a body surface area of >1.5 m<sup>2</sup>. The primary endpoint was response rate, while the secondary endpoints were progression-free survival, overall survival and safety. Results: Thirty-one patientswere enrolled in this study. The response and disease control rateswere 6.5 and 58.1%, respectively. Progression-free survival and median survival time were 2.8 and 12.6 months, respectively. Grade 3-4 adverse events were reported for 29.0% of the patients. Hematological toxicities of Grade 3 or 4 included leukopenia (9.7%), neutropenia (9.7%), febrile neutropenia (3.2%), thrombopenia (3.2%) and anemia (6.5%). Non-hematological toxicities of Grade 3 or 4 included pneumonitis (6.5%), diarrhea, colitis, dyspnea, rash, oral mucositis, anorexia and pulmonary thromboembolism/deep vein thrombosis (3.2% each). Conclusions: S-1 and irinotecan combination therapy at the present dose and schedule exhibited only modest efficacy with mild toxicities in previously treated patients with non-small cell lung cancer. No further clinical investigation with current dose and schedules is warranted for patients with non-small cell lung cancer who failed first-line platinum-based doublet chemotherapy.

Original languageEnglish
Pages (from-to)356-361
Number of pages6
JournalJapanese Journal of Clinical Oncology
Volume45
Issue number4
DOIs
Publication statusPublished - 2015 Apr 1

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irinotecan
Non-Small Cell Lung Carcinoma
Body Surface Area
Therapeutics
Disease-Free Survival
Appointments and Schedules
Safety
Febrile Neutropenia
Stomatitis
Survival
Leukopenia
Anorexia
Colitis
S 1 (combination)
Exanthema
Neutropenia
Platinum
Pulmonary Embolism
Venous Thrombosis
Thrombocytopenia

Keywords

  • Irinotecan
  • Non-small-cell lung cancer
  • Phase II trial
  • S-1
  • Second line

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

A Phase II study of S-1 and irinotecan combination therapy in previously treated patients with advanced non-small cell lung cancer. / Ikemura, Shinnosuke; Naoki, Katsuhiko; Yasuda, Hiroyuki; Kawada, Ichiro; Yoda, Satoshi; Terai, Hideki; Sato, Takashi; Ishioka, Kota; Arai, Daisuke; Ohgino, Keiko; Kamata, Hirofumi; Miyata, Jun; Kabata, Hiroki; Betsuyaku, Tomoko; Soejima, Kenzo.

In: Japanese Journal of Clinical Oncology, Vol. 45, No. 4, 01.04.2015, p. 356-361.

Research output: Contribution to journalArticle

Ikemura, Shinnosuke ; Naoki, Katsuhiko ; Yasuda, Hiroyuki ; Kawada, Ichiro ; Yoda, Satoshi ; Terai, Hideki ; Sato, Takashi ; Ishioka, Kota ; Arai, Daisuke ; Ohgino, Keiko ; Kamata, Hirofumi ; Miyata, Jun ; Kabata, Hiroki ; Betsuyaku, Tomoko ; Soejima, Kenzo. / A Phase II study of S-1 and irinotecan combination therapy in previously treated patients with advanced non-small cell lung cancer. In: Japanese Journal of Clinical Oncology. 2015 ; Vol. 45, No. 4. pp. 356-361.
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abstract = "Objective: This Phase II studywas conducted to evaluate the efficacy and safety of S-1 and irinotecan combination therapy as a second-line treatment in patients with advanced non-small cell lung cancer. Methods: Irinotecan was administered at 60 mg/m2 on Days 1 and 8. Oral S-1 was administered on Days 1-14 every 3 weeks at 80 mg/day for patients with a body surface area of <1.25 m2, 100 mg/day for patients with a body surface area of 1.25-1.5 m2 and 120 mg/day for patients with a body surface area of >1.5 m2. The primary endpoint was response rate, while the secondary endpoints were progression-free survival, overall survival and safety. Results: Thirty-one patientswere enrolled in this study. The response and disease control rateswere 6.5 and 58.1{\%}, respectively. Progression-free survival and median survival time were 2.8 and 12.6 months, respectively. Grade 3-4 adverse events were reported for 29.0{\%} of the patients. Hematological toxicities of Grade 3 or 4 included leukopenia (9.7{\%}), neutropenia (9.7{\%}), febrile neutropenia (3.2{\%}), thrombopenia (3.2{\%}) and anemia (6.5{\%}). Non-hematological toxicities of Grade 3 or 4 included pneumonitis (6.5{\%}), diarrhea, colitis, dyspnea, rash, oral mucositis, anorexia and pulmonary thromboembolism/deep vein thrombosis (3.2{\%} each). Conclusions: S-1 and irinotecan combination therapy at the present dose and schedule exhibited only modest efficacy with mild toxicities in previously treated patients with non-small cell lung cancer. No further clinical investigation with current dose and schedules is warranted for patients with non-small cell lung cancer who failed first-line platinum-based doublet chemotherapy.",
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AU - Ikemura, Shinnosuke

AU - Naoki, Katsuhiko

AU - Yasuda, Hiroyuki

AU - Kawada, Ichiro

AU - Yoda, Satoshi

AU - Terai, Hideki

AU - Sato, Takashi

AU - Ishioka, Kota

AU - Arai, Daisuke

AU - Ohgino, Keiko

AU - Kamata, Hirofumi

AU - Miyata, Jun

AU - Kabata, Hiroki

AU - Betsuyaku, Tomoko

AU - Soejima, Kenzo

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N2 - Objective: This Phase II studywas conducted to evaluate the efficacy and safety of S-1 and irinotecan combination therapy as a second-line treatment in patients with advanced non-small cell lung cancer. Methods: Irinotecan was administered at 60 mg/m2 on Days 1 and 8. Oral S-1 was administered on Days 1-14 every 3 weeks at 80 mg/day for patients with a body surface area of <1.25 m2, 100 mg/day for patients with a body surface area of 1.25-1.5 m2 and 120 mg/day for patients with a body surface area of >1.5 m2. The primary endpoint was response rate, while the secondary endpoints were progression-free survival, overall survival and safety. Results: Thirty-one patientswere enrolled in this study. The response and disease control rateswere 6.5 and 58.1%, respectively. Progression-free survival and median survival time were 2.8 and 12.6 months, respectively. Grade 3-4 adverse events were reported for 29.0% of the patients. Hematological toxicities of Grade 3 or 4 included leukopenia (9.7%), neutropenia (9.7%), febrile neutropenia (3.2%), thrombopenia (3.2%) and anemia (6.5%). Non-hematological toxicities of Grade 3 or 4 included pneumonitis (6.5%), diarrhea, colitis, dyspnea, rash, oral mucositis, anorexia and pulmonary thromboembolism/deep vein thrombosis (3.2% each). Conclusions: S-1 and irinotecan combination therapy at the present dose and schedule exhibited only modest efficacy with mild toxicities in previously treated patients with non-small cell lung cancer. No further clinical investigation with current dose and schedules is warranted for patients with non-small cell lung cancer who failed first-line platinum-based doublet chemotherapy.

AB - Objective: This Phase II studywas conducted to evaluate the efficacy and safety of S-1 and irinotecan combination therapy as a second-line treatment in patients with advanced non-small cell lung cancer. Methods: Irinotecan was administered at 60 mg/m2 on Days 1 and 8. Oral S-1 was administered on Days 1-14 every 3 weeks at 80 mg/day for patients with a body surface area of <1.25 m2, 100 mg/day for patients with a body surface area of 1.25-1.5 m2 and 120 mg/day for patients with a body surface area of >1.5 m2. The primary endpoint was response rate, while the secondary endpoints were progression-free survival, overall survival and safety. Results: Thirty-one patientswere enrolled in this study. The response and disease control rateswere 6.5 and 58.1%, respectively. Progression-free survival and median survival time were 2.8 and 12.6 months, respectively. Grade 3-4 adverse events were reported for 29.0% of the patients. Hematological toxicities of Grade 3 or 4 included leukopenia (9.7%), neutropenia (9.7%), febrile neutropenia (3.2%), thrombopenia (3.2%) and anemia (6.5%). Non-hematological toxicities of Grade 3 or 4 included pneumonitis (6.5%), diarrhea, colitis, dyspnea, rash, oral mucositis, anorexia and pulmonary thromboembolism/deep vein thrombosis (3.2% each). Conclusions: S-1 and irinotecan combination therapy at the present dose and schedule exhibited only modest efficacy with mild toxicities in previously treated patients with non-small cell lung cancer. No further clinical investigation with current dose and schedules is warranted for patients with non-small cell lung cancer who failed first-line platinum-based doublet chemotherapy.

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KW - Non-small-cell lung cancer

KW - Phase II trial

KW - S-1

KW - Second line

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