Efficacy and safety of capecitabine plus cisplatin in Japanese patients with advanced or metastatic gastric cancer: subset analyses of the AVAGAST study and the ToGA study

e15540 Background: Second-line chemotherapy can now be considered as a proven treatment option for metastatic or locally advanced gastric cancer (AGC). Two global randomized phase III trials (REGARD and RAINBOW) showed that survival benefit was significantly observed in patients treated with ramucirumab (RAM) alone and in combination with weekly doses of PTX, compared with placebo, respectively. The purpose of the study is to evaluate the efficacy and safety of weekly dose of PTX combined with RAM practically as the second-line treatment in Japanese patients with AGC refractory to an S-1-containing chemotherapy regimen. Methods: We conducted a retrospective review of the data of 18 patients with AGC who received more than 2 cycles of PTX/RAM combined chemotherapy as the second-line regimen following S-1-based treatment. The objective response rate (ORR), adverse events, progression-free survival (PFS) and overall survival (OS) were analyzed and compared with PTX monotherapy group. Results: Median number of courses were 5 for the PTX/RAM group and the discontinuation of treatment except for disease progression was found in 2 cases (33.3%). The rates of hematological toxicities of higher than grade 3 were 33.3% in the PTX/RAM group, which were higher than those found in the PTX groups. The tumor responses of the PTX/RAM group were 22% for the ORR and 78% for the DCR, compared with 21% and 48% in the PTX group, respectively. The dose intensities of PTX were 72.4% in the former group. The survival data showed that the MST after second-line exposure was 290 days and the median PFS was 131 days in the PTX/RAM group, compared with 159 days and 90 days in the PTX group, which were not significantly different. Conclusions: PTX/RAM might be one of the best regimens for Japanese patients with AGC as the second-line treatment following S-1-containing chemotherapy.

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Efficacy and Safety Study of Docetaxel as Salvage Chemotherapy in Metastatic Gastric Cancer Failing Fluoropyrimidine and Platinum Combination Chemotherapy

Cancer Research and Treatment ◽

10.4143/crt.2005.37.4.201 ◽

2005 ◽

Vol 37 (4) ◽

pp. 201 ◽

Cited By ~ 4

Author(s):

Jae-Lyun Lee ◽

Min-Hee Ryu ◽

Heung Moon Chang ◽

Tae-Won Kim ◽

Jeong Hwan Yook ◽

...

Keyword(s):

Gastric Cancer ◽

Combination Chemotherapy ◽

Metastatic Gastric Cancer ◽

Salvage Chemotherapy ◽

Efficacy And Safety ◽

Safety Study

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Efficacy and Safety of Dose-Dense Chemotherapy with Modified TCF Regimen (TCF-DD) in Elderly Patients with Metastatic Gastric Cancer (MGC)

Annals of Oncology ◽

10.1016/s0923-7534(20)33269-5 ◽

2012 ◽

Vol 23 ◽

pp. ix232

Author(s):

G. Tomasello ◽

W. Liguigli ◽

S. Lazzarelli ◽

R. Poli ◽

F.M. Negri ◽

...

Keyword(s):

Gastric Cancer ◽

Elderly Patients ◽

Metastatic Gastric Cancer ◽

Efficacy And Safety ◽

Dose Dense

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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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HER2 in gastric adenocarcinoma: where do we stand today?

Personalized Medicine ◽

10.2217/pme-2021-0004 ◽

2021 ◽

Author(s):

Khalil El Gharib ◽

Makram Khoury ◽

Hampig Raphael Kourie

Keyword(s):

Gastric Cancer ◽

Gastric Adenocarcinoma ◽

Survival Rates ◽

Metastatic Gastric Cancer ◽

Systematic Search ◽

Google Scholar ◽

Efficacy And Safety ◽

Pivotal Trial ◽

Gastric Adenocarcinomas

Aim: HER2 is a proto-oncogene expressed in 10–30% of gastric adenocarcinomas and is an ideal target for inhibition in malignancy with high recurrence and dismal survival rates. Materials & methods: A systematic search was conducted via PubMed, Google Scholar and the clinicaltrials.gov database to report the results of ongoing and past studies investigating HER2- inhibitors in gastric cancer. Results: Twenty-five studies were included; ToGA trial is the pivotal trial approving the use of trastuzumab in metastatic gastric cancer, followed by more studies investigating other HER2- inhibitors in this setting, as well as in local and locoregional malignancy. Conclusion: Anti-HER2 molecules are proving efficacy and safety in gastric cancer; the evidence is growing and association with other cancer agents is under investigation.

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