A Phase II Study of Irinotecan, Continuous 5-Fluorouracil, and Leucovorin (FOLFIRI) Combination Chemotherapy for Patients With Recurrent or Metastatic Gastric Cancer Previously Treated With a Fluoropyrimidine-Based Regimen

e15599 Background: The role of the second line chemotherapy in advanced gastric cancer was not clear, but possibility of prolongation of survival is open question. Irinotecan is promising agents in gastric cancer and this phase II study evaluated the efficacy and safety of combination chemotherapy with irinotecan, high dose of 5-fluorouracil (5-FU) and leucovorin in taxane and cisplatin based chemotherapy refractory metastatic gastric cancer. Methods: Eligible criteria were as followed; histologic confirmed adenocarcinoma of stomach, previously treated with taxane and cisplatin, age≥18, Eastern Clinical Oncology Group (ECOG) performance status of 1 or less, adequate organ function. Irinotecan (150 mg/m2) as a 30-min infusion and leucovorin (200 mg/m2) as a 15-min infusion were given on day 1, followed by 5-FU 400 mg/m2bolus infusion then 5-FU 2,400 mg/m2 as a 48-hour continuous infusion. This cycle was repeated every 2 weeks until disease progression or unacceptable toxicities. Results: Thirty-four patients were enrolled. The median age was 57 years (range 27–73 years), and the ECOG performance status of all patients was 1. All patients were evaluable for safety and survival and twenty seven patients (79.4%) were evaluable for tumor response. The overall response rate was 18.5% (95% CI: 3.9–33.1). The median progression free survival and overall survival were 4.6 (95% CI: 2.4–6.9) and 9.3 months (95% CI: 5.2–13.4), respectively. Greater than grade 3 haematological toxicities were neutropenia in nine (26.5%), febrile neutropenia in one (2.9%) and thrombocytopenia in one patient (2.9%). The major non-haematological toxicity was asthenia, but most of patients showed grade 1 or 2. Greater than grade 3 non- haematological toxicities were elevated AST/ALT in four (11.8%), hyperbilirubinemia in two (5.9%), nausea in two patients (5.9%). Conclusions: This results showed that the combination chemotherapy with irinotecan, 5-FU and leucovorin was well tolerated and active in taxane and cisplatin refractory patients. No significant financial relationships to disclose.

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Efficacy and safety of trastuzumab (T-mab) and paclitaxel for T-mab naïve patients with HER2 positive previously treated metastatic gastric cancer (JFMC45-1102).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.4_suppl.63 ◽

2013 ◽

Vol 31 (4_suppl) ◽

pp. 63-63

Author(s):

Akira Miki ◽

Kazuhiro Nishikawa ◽

Hirokazu Noshiro ◽

Akira Tsuburaya ◽

Yasunori Nishida ◽

...

Keyword(s):

Gastric Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Metastatic Gastric Cancer ◽

Phase Iii ◽

Left Ventricular Ejection ◽

Line Treatment ◽

Efficacy And Safety ◽

Her2 Positive ◽

Previously Treated

63 Background: The global, randomized, Phase III ToGA study showed that the first-line treatment of trastuzumab (T-mab) combined with capecitabine and cisplatin a survival (OS) benefit for patients (pts) with HER2-positive metastatic gastric cancer (mGC). However, there is no report concerning about the efficacy and safety of T-mab containing second-line treatment for T-mab naïve patients with HER2-positive mGC. Therefore, we planned a phase II study of paclitaxel plus trastuzumab in this setting. Methods: JFMC45-1102 is multicentre Phase II study. Patient (pts) with HER2 positive (IHC3+ or IHC2+/FISH+), histologically confirmed gastric adenocarcinoma, age≥20, received one or more prior chemotherapy but no prior therapy with T-mab, normal left ventricular ejection fraction (LVEF ≥ 50%) were eligible. Pts received paclitaxel (80 mg/m2on days 1, 8, and, 15 q4w) plus T-mab (8 mg/kg for the initial dose, followed by 6 mg/kg q3w) until disease progression, unacceptable toxicity or patient’s refusal. The primary endpoint was overall response rate evaluated according to RECIST ver1.0 (ORR; Threshold and expected ORR would be 15% and 30%), and the secondary endpoints include progression free survival (PFS), time to treatment failure (TTF), overall survival (OS) and safety. A LVEF assessment was repeated every three months. Results: Between November 2011 to March 2012, 45 pts were enrolled. Pts characteristics were: gender (M/F); 36/9, median age; 69, ECOG PS0/1/2; 34/10/1, advanced/recurrence; 25/20, number of prior treatment (1/2): 40/5. At 16 weeks, 43 pts were ORR and disease control rate (CR+PR+SD) were 37.2% (95% CI; 23.0%-53.3%) and 83.7%(95% CI; 69.3%-93.2%), respectively. The LVEF assessment was performed in 31 patients. More than 10% decrease in LVEF was observed in only one patient, although total incidence of decrease in LVEF was 56% (17/31 pts). Conclusions: Combination chemotherapy of paclitaxel plus trastuzumab is generally well tolerated and showed promising activity for T-mab native patients with HER2-positive previously treated advanced or recurrent gastric cancer. Clinical trial information: UMIN000006223.

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Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer

Cancer Chemotherapy and Pharmacology ◽

10.1007/s00280-009-1215-2 ◽

2009 ◽

Vol 66 (4) ◽

pp. 721-728 ◽

Cited By ~ 50

Author(s):

Yasushi Sato ◽

Tetsuji Takayama ◽

Tamotsu Sagawa ◽

Yasuo Takahashi ◽

Hiroyuki Ohnuma ◽

...

Keyword(s):

Gastric Cancer ◽

Phase Ii ◽

Combination Chemotherapy ◽

Phase Ii Study ◽

Metastatic Gastric Cancer

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Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic gastric cancer

Cancer Chemotherapy and Pharmacology ◽

10.1007/s00280-006-0253-2 ◽

2006 ◽

Vol 59 (1) ◽

pp. 17-21 ◽

Cited By ~ 15

Author(s):

Keon Woo Park ◽

Jin Seok Ahn ◽

Young Suk Park ◽

Jeeyun Lee ◽

Jung Hoon Kang ◽

...

Keyword(s):

Gastric Cancer ◽

Phase Ii ◽

Combination Chemotherapy ◽

Phase Ii Study ◽

Metastatic Gastric Cancer

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Phase II Study of a Combination of Irinotecan and Cisplatin Against Metastatic Gastric Cancer

Journal of Clinical Oncology ◽

10.1200/jco.1999.17.1.319 ◽

1999 ◽

Vol 17 (1) ◽

pp. 319-319 ◽

Cited By ~ 184

Author(s):

Narikazu Boku ◽

Atsushi Ohtsu ◽

Yasuhiro Shimada ◽

Kuniaki Shirao ◽

Shigeki Seki ◽

...

Keyword(s):

Gastric Cancer ◽

Phase Ii ◽

Combination Chemotherapy ◽

Response Rate ◽

Chemotherapy Regimen ◽

Phase Ii Study ◽

Metastatic Gastric Cancer ◽

Phase Iii ◽

Prior Chemotherapy ◽

Combination Chemotherapy Regimen

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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