Journal of Clinical Oncology, Vol 17, Issue 1
(January), 1999: 319
© 1999 American Society for Clinical Oncology
Phase II Study of a Combination of Irinotecan and Cisplatin Against Metastatic Gastric Cancer
Narikazu Boku,
Atsushi Ohtsu,
Yasuhiro Shimada,
Kuniaki Shirao,
Shigeki Seki,
Hiroshi Saito,
Yuh Sakata,
Ichinosuke Hyodo
From the Department of Gastrointestinal Oncology and Gastroenterology, National Cancer Center Hospital East, Kashiwa; Department of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo; Department of Internal Medicine, Saku Central Hospital, Minami-Saku; Department of Internal Medicine, Yamagata Prefectural Central Hospital, Yamagata; Department of Gastroenterology, Aomori Prefectural Central Hospital, Aomori; and Department of Internal Medicine, National Shikoku Cancer Center Hospital, Matsuyama, Japan.
Address reprint requests to Narikazu Boku, Department of Gastrointestinal Oncology and Gastroenterology, National Cancer Center Hospital East, 6–5-1 Kashiwanoha, Kashiwa, Chiba 277–8577, Japan.
PURPOSE: A phase II study of a combination chemotherapy regimen of cisplatin (CDDP) and irinotecan (CPT-11) was conducted to assess its efficacy and feasibility in patients with metastatic gastric cancer.
PATIENTS AND METHODS: Eligibility criteria included the following: (1) histologically proven gastric cancer with measurable metastatic lesions, (2) performance status of 2 or less, (3) age of 75 years or younger, (4) one or no prior chemotherapy regimens, (5) adequate bone marrow, liver, renal, and cardiac functions, and (6) written informed consent. The treatment consisted of CPT-11 (70 mg/m2) on day 1 and day 15 and CDDP (80 mg/m2) on day 1, repeated every 4 weeks.
RESULTS: Forty-four patients were entered onto the study. The overall response rate was 48% (21 of 44 patients, 95% confidence interval [CI], 33% to 63%) and included one complete remission (2%). The response rate of the patients who had not received prior chemotherapy was 59% (17 of 29 patients, 95% CI, 39% to 77%). The median survival time was 272 days for all patients and 322 days for the 29 patients who had not received prior chemotherapy. Grade 4 neutropenia was observed in 25 patients (57%), and grade 3 or 4 diarrhea was observed in nine patients (20%). Other adverse reactions were mild. No treatment-related deaths occurred.
CONCLUSION: This combination chemotherapy regimen is active and well tolerated. It may be an appropriate regimen for future phase III trials.
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Irinotecan Plus Cisplatin Therapy and S-1 Plus Cisplatin Therapy for Advanced or Recurrent Gastric Cancer in a Single Institution
Jpn. J. Clin. Oncol.,
December 1, 2008;
38(12):
810 - 815.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Dank, J. Zaluski, C. Barone, V. Valvere, S. Yalcin, C. Peschel, M. Wenczl, E. Goker, L. Cisar, K. Wang, et al.
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Ann. Onc.,
August 1, 2008;
19(8):
1450 - 1457.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Theodore, I. Skoneczna, I. Bodrogi, M. Leahy, J. M. Kerst, L. Collette, K. Ven, S. Marreaud, R. D. T. Oliver, and for the EORTC Genito-Urinary Tract Cancer Group
A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992)
Ann. Onc.,
July 1, 2008;
19(7):
1304 - 1307.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. Chin, S. Baba, H. Hosaka, A. Ishiyama, N. Mizunuma, E. Shinozaki, M. Suenaga, T. Kozuka, Y. Seto, N. Yamamoto, et al.
Irinotecan Plus Cisplatin for Therapy of Small-cell Carcinoma of the Esophagus: Report of 12 Cases from Single Institution Experience
Jpn. J. Clin. Oncol.,
June 2, 2008;
(2008)
hyn041v1.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Jeong, H.-C. Jeung, S. Y. Rha, C. K. Im, S. J. Shin, J. B. Ahn, S. H. Noh, J. K. Roh, and H. C. Chung
Phase II study of combination chemotherapy of 5-fluorouracil, low-dose leucovorin, and oxaliplatin (FLOX regimen) in pretreated advanced gastric cancer
Ann. Onc.,
June 1, 2008;
19(6):
1135 - 1140.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. Matsubara, Y. Yamada, Y. Hirashima, D. Takahari, N. T. Okita, K. Kato, T. Hamaguchi, K. Shirao, Y. Shimada, and T. Shimoda
Impact of Insulin-Like Growth Factor Type 1 Receptor, Epidermal Growth Factor Receptor, and HER2 Expressions on Outcomes of Patients with Gastric Cancer
Clin. Cancer Res.,
May 15, 2008;
14(10):
3022 - 3029.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S.-G. Kim, S. Y. Oh, H.-C. Kwon, S. Lee, J. H. Kim, S.-H. Kim, and H.-J. Kim
A Phase II Study of Irinotecan with Bi-weekly, Low-dose Leucovorin and Bolus and Continuous Infusion 5-fluorouracil (Modified FOLFIRI) as Salvage Therapy for Patients with Advanced or Metastatic Gastric Cancer
Jpn. J. Clin. Oncol.,
October 8, 2007;
(2007)
hym103v1.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
N. Boku, A. Ohtsu, S. Yoshida, K. Shirao, Y. Shimada, I. Hyodo, H. Saito, Y. Miyata, and Gastrointestinal Oncology Study Group of Japan Cli
Significance of Biological Markers for Predicting Prognosis and Selecting Chemotherapy Regimens of Advanced Gastric Cancer Patients between Continuous Infusion of 5-FU and a Combination of 5-FU and Cisplatin
Jpn. J. Clin. Oncol.,
May 23, 2007;
(2007)
hym015v1.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. Yamazaki, N. Boku, K. Shibamoto, H. Yasui, A. Fukutomi, T. Yoshino, S. Hironaka, Y. Onozawa, Y. Otake, N. Hasuike, et al.
The Role of the Outpatient Clinic in Chemotherapy for Patients with Unresectable or Recurrent Gastric Cancer
Jpn. J. Clin. Oncol.,
February 1, 2007;
37(2):
96 - 101.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. A. Shah, R. K. Ramanathan, D. H. Ilson, A. Levnor, D. D'Adamo, E. O'Reilly, A. Tse, R. Trocola, L. Schwartz, M. Capanu, et al.
Multicenter Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
J. Clin. Oncol.,
November 20, 2006;
24(33):
5201 - 5206.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. J. Schaaf, L. A. Hammond, S. J. Tipping, R. M. Goldberg, R. Goel, J. G. Kuhn, L. L. Miller, L. D. Compton, L. A. Cisar, G. L. Elfring, et al.
Phase 1 and pharmacokinetic study of intravenous irinotecan in refractory solid tumor patients with hepatic dysfunction.
Clin. Cancer Res.,
June 15, 2006;
12(12):
3782 - 3791.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. Yoshida, M. Ninomiya, N. Takakura, N. Hirabayashi, W. Takiyama, Y. Sato, S. Todo, M. Terashima, M. Gotoh, J. Sakamoto, et al.
Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer.
Clin. Cancer Res.,
June 1, 2006;
12(11):
3402 - 3407.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Ohtsu, S. Yoshida, and N. Saijo
Disparities in Gastric Cancer Chemotherapy Between the East and West
J. Clin. Oncol.,
May 10, 2006;
24(14):
2188 - 2196.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. Nagashima, N. Boku, A. Ohtsu, S. Yoshida, T. Hasebe, A. Ochiai, Y. Sakata, H. Saito, Y. Miyata, I. Hyodo, et al.
Biological Markers as a Predictor for Response and Prognosis of Unresectable Gastric Cancer Patients Treated with Irinotecan and Cisplatin
Jpn. J. Clin. Oncol.,
December 1, 2005;
35(12):
714 - 719.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. A. Ajani
Evolving Chemotherapy for Advanced Gastric Cancer
Oncologist,
October 1, 2005;
10(suppl_3):
49 - 58.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. Takiuchi, H. Narahara, T. Tsujinaka, M. Gotoh, S.-i. Kawabe, K.-i. Katsu, H. Iishi, M. Tatsuta, K. Fujitani, H. Furukawa, et al.
Phase I Study of S-1 Combined with Irinotecan (CPT-11) in Patients with Advanced Gastric Cancer (OGSG 0002)
Jpn. J. Clin. Oncol.,
September 1, 2005;
35(9):
520 - 525.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. A. Shah, D. Ilson, and D. P. Kelsen
Thromboembolic Events in Gastric Cancer: High Incidence in Patients Receiving Irinotecan- and Bevacizumab-Based Therapy
J. Clin. Oncol.,
April 10, 2005;
23(11):
2574 - 2576.
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Pozzo, C. Barone, J. Szanto, E. Padi, C. Peschel, J. Bukki, V. Gorbunova, V. Valvere, J. Zaluski, M. Biakhov, et al.
Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: results of a randomized phase II study
Ann. Onc.,
December 1, 2004;
15(12):
1773 - 1781.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. S. Wohrer, M. Raderer, and M. Hejna
Palliative chemotherapy for advanced gastric cancer
Ann. Onc.,
November 1, 2004;
15(11):
1585 - 1595.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Yamao, K. Ohta, S. Ohyama, S. Ishihara, K. Chin, M. Maruyama, T. Takahashi, and T. Nakajima
A Preliminary Study of Preoperative Chemotherapy Combining Irinotecan and Cisplatin in Patients with Gastric Cancer with Unresectable Para-aortic Lymph Node Metastases
Jpn. J. Clin. Oncol.,
May 1, 2004;
34(5):
255 - 261.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Y. Ueda, H. Yamagishi, T. Yamashita, N. Itoh, H. Itoi, T. Shirasaka, and J. A. Ajani
S-1-Induced, Prolonged Complete Regression of Lung Metastasis from Gastric Cancer Refractory to 5'-DFUR: a Case Report with Pharmacokinetic Study
Jpn. J. Clin. Oncol.,
May 1, 2004;
34(5):
282 - 286.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. H. Chun, H. K. Kim, J. S. Lee, J. Y. Choi, H. G. Lee, S. M. Yoon, I. J. Choi, K. W. Ryu, Y.-W. Kim, and J.-M. Bae
Weekly Irinotecan in Patients with Metastatic Gastric Cancer Failing Cisplatin-based Chemotherapy
Jpn. J. Clin. Oncol.,
January 1, 2004;
34(1):
8 - 13.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. Assersohn, G. Brown, D. Cunningham, C. Ward, J. Oates, J. S. Waters, M. E. Hill, and A. R. Norman
Phase II study of irinotecan and 5-fluorouracil/leucovorin in patients with primary refractory or relapsed advanced oesophageal and gastric carcinoma
Ann. Onc.,
January 1, 2004;
15(1):
64 - 69.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Y. Kodera, S. Ito, Y. Yamamura, Y. Mochizuki, M. Fujiwara, K. Hibi, K. Ito, S. Akiyama, and A. Nakao
Follow-Up Surveillance for Recurrence After Curative Gastric Cancer Surgery Lacks Survival Benefit
Ann. Surg. Oncol.,
October 1, 2003;
10(8):
898 - 902.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C.-J. Tai, J.-H. Liu, W.-S. Chen, J.-K. Lin, W.-S. Wang, C.-C. Yen, T.-J. Chiou, and P.-M. Chen
Irinotecan (CPT11) Plus High-dose 5-Fluorouracil (5-FU) and Leucovorin (LV) as Salvage Therapy for Metastatic Colorectal Cancer (MCRC) after Failed Oxaliplatin Plus 5-FU and LV: a Pilot Study in Taiwan
Jpn. J. Clin. Oncol.,
March 1, 2003;
33(3):
136 - 140.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Ohtsu, Y. Shimada, K. Shirao, N. Boku, I. Hyodo, H. Saito, N. Yamamichi, Y. Miyata, N. Ikeda, S. Yamamoto, et al.
Randomized Phase III Trial of Fluorouracil Alone Versus Fluorouracil Plus Cisplatin Versus Uracil and Tegafur Plus Mitomycin in Patients With Unresectable, Advanced Gastric Cancer: The Japan Clinical Oncology Group Study (JCOG9205)
J. Clin. Oncol.,
January 1, 2003;
21(1):
54 - 59.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
W H Allum, S M Griffin, A Watson, and D Colin-Jones
Guidelines for the management of oesophageal and gastric cancer
Gut,
June 1, 2002;
50
(2007):
v1 - v23.
[Full Text]
[PDF]
|
|
|
|
|
|
|
N. Boku, A. Ohtsu, F. Nagashima, M. Muto, T. Shinkai, and S. Yoshida
Retrospective Study of Hyponatremia in Gastric Cancer Patients Treated with a Combination Chemotherapy of 5-Fluorouracil and Cisplatin: a Possible Warning Sign of Severe Hematological Toxicities?
Jpn. J. Clin. Oncol.,
August 1, 2001;
31(8):
382 - 387.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. L. Rothenberg
Irinotecan (CPT-11): Recent Developments and Future Directions-Colorectal Cancer and Beyond
Oncologist,
February 1, 2001;
6(1):
66 - 80.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
D. H. Ilson, L. Saltz, P. Enzinger, Y. Huang, A. Kornblith, M. Gollub, E. O'Reilly, G. Schwartz, J. DeGroff, G. Gonzalez, et al.
Phase II Trial of Weekly Irinotecan Plus Cisplatin in Advanced Esophageal Cancer
J. Clin. Oncol.,
October 1, 1999;
17(10):
3270 - 3275.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
