Phase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer

Takuji Okusaka, Junji Furuse, Akihiro Funakoshi, Tatsuya Ioka, Kenji Yamao, Shinichi Ohkawa, Narikazu Boku, Yoshito Komatsu, Shoji Nakamori, Haruo Iguchi, Tetsuhide Ito, Kazuhiko Nakagawa, Kohei Nakachi

研究成果: ジャーナルへの寄稿記事

47 引用 (Scopus)

抄録

Erlotinib combined with gemcitabine has not been evaluated in Japanese patients with unresectable pancreatic cancer. This two-step phase II study assessed the safety and pharmacokinetics of erlotinib 100mg/day (oral) plus gemcitabine 1000mg/m2 (i.v. days 1, 8, 15) in a 28-day cycle in the first step, and efficacy and safety in the second step. The primary end-point was safety. One hundred and seven patients were enrolled (first step, n=6; second step, n=101). The most common adverse event was RASH (compiled using the preferred terms rash, acne, exfoliative rash, dermatitis acneiform, erythema, eczema, dermatitis and pustular rash) in 93.4% of patients. One treatment-related death occurred. While interstitial lung disease-like events were reported in nine patients (8.5%; grade 1/2/3, 3.8/2.8/1.9%), all patients recovered or improved. The median overall survival, the 1-year survival rate and median progression-free survival were 9.23months, 33.0% and 3.48months, respectively. The overall response and disease control rates were 20.3% and 50.0%, respectively. In Japanese patients with unresectable pancreatic cancer, erlotinib plus gemcitabine had acceptable toxicity and efficacy that was not inferior to that seen in Western patients. (Cancer Sci 2011; 102: 425-431)

元の言語英語
ページ(範囲)425-431
ページ数7
ジャーナルCancer Science
102
発行部数2
DOI
出版物ステータス出版済み - 2 1 2011

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gemcitabine
Pancreatic Neoplasms
Exanthema
Safety
Exfoliative Dermatitis
Eczema
Interstitial Lung Diseases
Acne Vulgaris
Dermatitis
Erythema
Erlotinib Hydrochloride
Disease-Free Survival
Survival Rate
Pharmacokinetics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

これを引用

Okusaka, T., Furuse, J., Funakoshi, A., Ioka, T., Yamao, K., Ohkawa, S., ... Nakachi, K. (2011). Phase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer. Cancer Science, 102(2), 425-431. https://doi.org/10.1111/j.1349-7006.2010.01810.x

Phase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer. / Okusaka, Takuji; Furuse, Junji; Funakoshi, Akihiro; Ioka, Tatsuya; Yamao, Kenji; Ohkawa, Shinichi; Boku, Narikazu; Komatsu, Yoshito; Nakamori, Shoji; Iguchi, Haruo; Ito, Tetsuhide; Nakagawa, Kazuhiko; Nakachi, Kohei.

:: Cancer Science, 巻 102, 番号 2, 01.02.2011, p. 425-431.

研究成果: ジャーナルへの寄稿記事

Okusaka, T, Furuse, J, Funakoshi, A, Ioka, T, Yamao, K, Ohkawa, S, Boku, N, Komatsu, Y, Nakamori, S, Iguchi, H, Ito, T, Nakagawa, K & Nakachi, K 2011, 'Phase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer', Cancer Science, 巻. 102, 番号 2, pp. 425-431. https://doi.org/10.1111/j.1349-7006.2010.01810.x
Okusaka, Takuji ; Furuse, Junji ; Funakoshi, Akihiro ; Ioka, Tatsuya ; Yamao, Kenji ; Ohkawa, Shinichi ; Boku, Narikazu ; Komatsu, Yoshito ; Nakamori, Shoji ; Iguchi, Haruo ; Ito, Tetsuhide ; Nakagawa, Kazuhiko ; Nakachi, Kohei. / Phase II study of erlotinib plus gemcitabine in Japanese patients with unresectable pancreatic cancer. :: Cancer Science. 2011 ; 巻 102, 番号 2. pp. 425-431.
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abstract = "Erlotinib combined with gemcitabine has not been evaluated in Japanese patients with unresectable pancreatic cancer. This two-step phase II study assessed the safety and pharmacokinetics of erlotinib 100mg/day (oral) plus gemcitabine 1000mg/m2 (i.v. days 1, 8, 15) in a 28-day cycle in the first step, and efficacy and safety in the second step. The primary end-point was safety. One hundred and seven patients were enrolled (first step, n=6; second step, n=101). The most common adverse event was RASH (compiled using the preferred terms rash, acne, exfoliative rash, dermatitis acneiform, erythema, eczema, dermatitis and pustular rash) in 93.4{\%} of patients. One treatment-related death occurred. While interstitial lung disease-like events were reported in nine patients (8.5{\%}; grade 1/2/3, 3.8/2.8/1.9{\%}), all patients recovered or improved. The median overall survival, the 1-year survival rate and median progression-free survival were 9.23months, 33.0{\%} and 3.48months, respectively. The overall response and disease control rates were 20.3{\%} and 50.0{\%}, respectively. In Japanese patients with unresectable pancreatic cancer, erlotinib plus gemcitabine had acceptable toxicity and efficacy that was not inferior to that seen in Western patients. (Cancer Sci 2011; 102: 425-431)",
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AU - Ioka, Tatsuya

AU - Yamao, Kenji

AU - Ohkawa, Shinichi

AU - Boku, Narikazu

AU - Komatsu, Yoshito

AU - Nakamori, Shoji

AU - Iguchi, Haruo

AU - Ito, Tetsuhide

AU - Nakagawa, Kazuhiko

AU - Nakachi, Kohei

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