The efficacy and toxicity of 3-weekly TS-1 containing chemotherapy in patients with unresectable advanced gastric cancer.

e14580 Background: TS-1 has shown good efficacy against unresectable advanced gastric cancer (AGC). Conventionally TS-1 containing chemotherapy (CTx) is performed on 5-weekly or 6-weekly basis. We lack robust evidence for the efficacy and safety of 3-weekly TS-1 containing CTx. In Korea, 3-weekly TS-1 containing CTx can be used as off-label under permission of Health Insurance Review and Assessment service (HIRA). We and HIRA conducted this study to confirm the efficacy and tolerability of 3-weekly TS-1 containing CTx in unresectable AGC. Methods: We retrospectively analyzed patients with unresectable AGC who received 3-weekly TS-1 containing CTx between June 2007 and January 2011. In 3-weekly TS-1 monotherapy, TS-1 40-60mg depending on patient’s body surface area was administered orally twice a day for 14 days followed by a 1-week rest every 3 weeks. In 3-weekly TS-1/cisplatin combination CTx, TS-1 40mg/m2 was given orally twice a day for 14 days followed by 1-week rest and cisplatin 60 mg/m2 on day 1 was given by intravenous infusion every 3 weeks. Results: A total of 1372 patients (TS-1 monotherapy: 265 (19.3%), TS-1/cisplatin : 1107 (80.7%)) were enrolled from 31 institutions. Response rate of 3-weekly TS-1 monotherapy was 18.1%. Progression-free survival (PFS) and overall survival (OS) were 5.2 months (95% C.I., 4.5-5.9) and 14.3 months (95% C.I., 10.6-17.9), respectively. Response rate of 3-weekly TS-1/cisplatin was 29.4%. PFS and OS of 3-weekly TS-1/cisplatin were 6.8 months (95% C.I., 6.3-7.4) and 16.1 months (95% C.I., 14.4-17.9) respectively. Common toxicities of TS-1 monotherapy included nausea/vomiting (N/V) (13.6%), anemia (13.2%) and neutropenia (10.2%). However, the incidences of more grade 3/4 toxicities were less than 3.0%. All grades of neutropenia, N/V and anemia occurred in 35.4%, 21.1% and 13.3% of patients receiving 3-weekly TS-1/cisplatin. However, grade 3/4 toxicities including neutropenia, N/V and anemia occurred in only 17.8%, 3.0% and 2.9%. Conclusions: Three-weekly TS-1 monotherapy or TS-1/cisplatin CTx showed good efficacy and well tolerability. Our study suggests that 3-weekly scheduled regimens may be a good treatment option for unresectable AGC patients.

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A phase ll study of new combination regimen with trastuzumab, S-1, and CDDP in HER2-positive advanced gastric cancer (HERBIS-1).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.4072 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 4072-4072

Author(s):

Keisuke Koeda ◽

Naotoshi Sugimoto ◽

Junji Tanaka ◽

Masahiro Tsuda ◽

Wataru Okamoto ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Advanced Gastric Cancer ◽

Response Rate ◽

Progression Free Survival ◽

New Combination ◽

Combination Regimen ◽

Her2 Positive ◽

Threshold Response ◽

Grade 3

4072 Background: S-1, a novel oral fluoropyrimidine, plus cisplatin (SP) regimen is one of the standard chemotherapy as first-line for advanced gastric cancer. ToGA study demonstrated that trastuzumab (T-mab) combination regimen improved the overall survival of patients with HER2-positive advanced gastric cancer. However, there was no study evaluating the efficacy and the safety of T-mab in combination with S-1 plus cisplatin (SP) regimen. Therefore, we planned this study to examine the efficacy and the safety of the SP plus T-mab. Methods: Patients confirmed to be HER2-positive by IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive) received S-1 at 80 mg/m2 po, day 1-14, and cisplatin 60 mg/m2 iv, day 1 plus trastuzumab 8 mg/kg iv, day 1 (6 mg/kg iv, d1 from 2nd course), repeated every 3 weeks until disease progression. Primary endpoint was response rate (RR). Secondary endpoints were progression-free survival, overall survival and safety. The threshold response rate was defined as 35%, and the expected rate was set at 50% with a 80% power and a 1-sided alpha value of 0.1 and the calculated sample size was 50 patients. Results: A total of 56 patients (median age 66) were enrolled in this study. The efficacy and the safety analyses were conducted in the full analysis set of 53 patients. (Two patients were excluded for ineligibility and one was for no treatment). The confirmed RR assessed by the independent review committee was 67.9% (95% CI: 53.7 – 80.1), and the disease control rate was 94.3%. The median PFS was 7.1 months (95% CI: 6.0 – 10.1). The median OS was not reached. (The median follow-up time: 9.2 months) The main grade 3/4 adverse events were as follows: neutropenia 34%, leucopenia 8%, anorexia 23%, diarrhea 8%, hypoalbuminemia 4%, vomiting 6%, and increased creatinine 6%. Conclusions: This tri-week regimen with SP plus T-mab showed promising results in patients with HER2-positive advanced gastric cancer. Clinical trial information: UMIN000005739.

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Retrospective cohort study of nanoparticle albumin-bound paclitaxel plus ramucirumab versus paclitaxel plus ramucirumab as second-line treatment in patients with advanced gastric cancer

BMC Cancer ◽

10.1186/s12885-020-07614-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Mashiro Okunaka ◽

Daisuke Kotani ◽

Ken Demachi ◽

Akihito Kawazoe ◽

Takayuki Yoshino ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Progression Free Survival ◽

Similar Efficacy ◽

Hazard Ratio ◽

Line Treatment ◽

Second Line ◽

Efficacy And Safety ◽

Free Survival ◽

Grade 3

Abstract Background Nanoparticle albumin-bound paclitaxel (nab-PTX) has shown non-inferiority to paclitaxel (PTX) as second-line therapy for advanced gastric cancer (AGC) with fewer infusion-related reactions. The efficacy and safety of nab-PTX plus ramucirumab (RAM) was reported in a phase II trial; however, there is no randomized trial comparing this regimen with PTX plus RAM in patients with AGC. This retrospective study aimed to investigate the efficacy and safety of nab-PTX plus RAM versus PTX plus RAM in patients with AGC. Methods This study included patients with AGC who received nab-PTX plus RAM from September 2017 to January 2019 or PTX plus RAM from June 2015 to August 2017 as second-line chemotherapy in our hospital. Results A total of 113 and 138 patients who received nab-PTX plus RAM and PTX plus RAM, respectively, were analyzed. Median progression-free survival (PFS) was 3.9 months (95% confidence interval [CI]: 3.4–4.3) in the nab-PTX plus RAM group and 3.9 months (95% CI: 3.1–4.7) in the PTX plus RAM group (hazard ratio [HR]: 1.08; 95% CI: 0.83–1.40; P = 0.573). Median overall survival (OS) was 10.9 months (95% CI: 9.3–12.7) in the nab-PTX plus RAM group and 10.3 months (95% CI: 8.5–12.0) in the PTX plus RAM group (hazard ratio: 0.82; 95% CI: 0.61–1.10; P = 0.188). In patients with moderate/massive ascites, favorable outcomes for progression-free survival were observed in the nab-PTX plus RAM group compared with the PTX plus RAM group. Although anemia and fatigue (any grade) were more frequent in the nab-PTX plus RAM group, discontinuation of study treatment was not increased in the nab-PTX plus RAM group. There was no occurrence of hypersensitivity reaction in the nab-PTX plus RAM group, while two patients (1.4%) experienced grade 3 hypersensitivity reactions in the PTX plus RAM group. Conclusions The combination of nab-PTX plus RAM showed a similar efficacy and safety profile to PTX plus RAM as second-line treatment for patients with AGC.

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Bevacizumab in Combination With Chemotherapy As First-Line Therapy in Advanced Gastric Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

Journal of Clinical Oncology ◽

10.1200/jco.2011.36.2236 ◽

2011 ◽

Vol 29 (30) ◽

pp. 3968-3976 ◽

Cited By ~ 711

Author(s):

Atsushi Ohtsu ◽

Manish A. Shah ◽

Eric Van Cutsem ◽

Sun Young Rha ◽

Akira Sawaki ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Overall Response Rate ◽

Response Rate ◽

Progression Free Survival ◽

Line Treatment ◽

First Line ◽

Free Survival ◽

Overall Response ◽

First Line Treatment

Purpose The Avastin in Gastric Cancer (AVAGAST) trial was a multinational, randomized, placebo-controlled trial designed to evaluate the efficacy of adding bevacizumab to capecitabine-cisplatin in the first-line treatment of advanced gastric cancer. Patients and Methods Patients received bevacizumab 7.5 mg/kg or placebo followed by cisplatin 80 mg/m2 on day 1 plus capecitabine 1,000 mg/m2 twice daily for 14 days every 3 weeks. Fluorouracil was permitted in patients unable to take oral medications. Cisplatin was given for six cycles; capecitabine and bevacizumab were administered until disease progression or unacceptable toxicity. The primary end point was overall survival (OS). Log-rank test was used to test the OS difference. Results In all, 774 patients were enrolled; 387 were assigned to each treatment group (intention-to-treat population), and 517 deaths were observed. Median OS was 12.1 months with bevacizumab plus fluoropyrimidine-cisplatin and 10.1 months with placebo plus fluoropyrimidine-cisplatin (hazard ratio 0.87; 95% CI, 0.73 to 1.03; P = .1002). Both median progression-free survival (6.7 v 5.3 months; hazard ratio, 0.80; 95% CI, 0.68 to 0.93; P = .0037) and overall response rate (46.0% v 37.4%; P = .0315) were significantly improved with bevacizumab versus placebo. Preplanned subgroup analyses revealed regional differences in efficacy outcomes. The most common grade 3 to 5 adverse events were neutropenia (35%, bevacizumab plus fluoropyrimidine-cisplatin; 37%, placebo plus fluoropyrimidine-cisplatin), anemia (10% v 14%), and decreased appetite (8% v 11%). No new bevacizumab-related safety signals were identified. Conclusion Although AVAGAST did not reach its primary objective, adding bevacizumab to chemotherapy was associated with significant increases in progression-free survival and overall response rate in the first-line treatment of advanced gastric cancer.

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Retrospective cohort study of nanoparticle albumin-bound paclitaxel plus ramucirumab versus paclitaxel plus ramucirumab as second-line treatment in patients with advanced gastric cancer

10.21203/rs.3.rs-26226/v1 ◽

2020 ◽

Author(s):

Mashiro Okunaka ◽

Daisuke Kotani ◽

Ken Demachi ◽

Akihito Kawazoe ◽

Takayuki Yoshino ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Progression Free Survival ◽

Similar Efficacy ◽

Hazard Ratio ◽

Line Treatment ◽

Second Line ◽

Efficacy And Safety ◽

Free Survival ◽

Grade 3

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Phase II study of S-1 monotherapy in taxane, cisplatin refractory gastric cancer

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.4551 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 4551-4551

Author(s):

S. Cho ◽

S. Lee ◽

J. Hwang ◽

W. Bae ◽

H. Shim ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Advanced Gastric Cancer ◽

Clinical Benefit ◽

Phase Ii Study ◽

Progression Free Survival ◽

Salvage Chemotherapy ◽

Free Survival ◽

Previously Treated ◽

Grade 3

4551 Background: S-1 is a fourth-generation oral fluoropyrimidine that was developed to mimic protracted continuous infusion of 5-fluorouracil (5-FU). In previous study, S-1 demonstrated promising activity which is comparable to combination chemotherapy in advanced gastric cancer. This phase II study evaluated the efficacy and safety of S-1 salvage chemotherapy, in patients with taxane and cisplatin refractory gastric cancer. The primary end point was progression free survival and secondary end points were overall survival, safety and clinical benefit. Methods: Patients were eligible if they had histologically documented gastric adenocarcinoma previously treated with taxane (docetaxel or paclitaxel) and cisplatin; age≥18; Eastern Clinical Oncology Group (ECOG) performance status of 2 or less; adequate organ function; no evidence of gastrointestinal obstruction or passage disturbance. S-1 treatment was performed according to BSA as followed; < BSA 1.25, 80 mg/day, 1.25 ≤ BSA < 1.5, 100 mg/day; BSA ≥ 1.5, 120 mg/day. Every dosage was delivered divided two times and administered for 4 weeks followed by 2 weeks of resting period. Treatment continued until progression of disease or life-threatening adverse events were occurred. Results: Fifty-four patients were enrolled in this study and of the patients, forty-eight patients were evaluable. A total 194 chemotherapy cycles were administered and median number of cycles was three. Four (8.3%) patients had a partial response and 18 (37.5%) patients had stable disease. The median progression free survival and overall survival were 3.8 and 10.2 months, respectively. Grade III/IV hematologic toxicities included neutropenia in 6 patients (12.5%) and there was no febrile neutropenia. Most of nonhematologic toxicities were diarrhea, asthenia, and mucositis, and there was no grade 3 or grade 4 except two patients, who developed grade 3 anorexia and diarrhea, respectively. The clinical benefit response was observed in 16 patients (33.3%). Conclusions: This results showed that S-1 monotherapy was active and safe salvage chemotherapy in patients with advanced gastric cancer previously treated with taxane and cisplatin. No significant financial relationships to disclose.

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Efficacy and safety of FOLFIRI regimen in elderly versus nonelderly patients with advanced colorectal and gastric cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.701 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. 701-701

Author(s):

Jin Won Kim ◽

Kyu-Pyo Kim ◽

Ju Hyun Lee ◽

Yong Sang Hong ◽

Sun Young Kim ◽

...

Keyword(s):

Gastric Cancer ◽

Response Rate ◽

Age Groups ◽

Dose Intensity ◽

Progression Free Survival ◽

Efficacy And Safety ◽

Elderly Age ◽

Free Survival ◽

Grade 3 ◽

Two Age Groups

701 Background: Irinotecan-based chemotherapy is a standard backbone in patients (pts) with advanced colorectal (CRC) or gastric cancer (GC). However, there is still a paucity of information concerning the efficacy and safety of irinotecan-based regimen in elderly pts. Methods: Using pt cohort (N = 1,545) of the UGT1A1 genotype study (Kim KP, et al. J Clin Oncol 33, 2015 (suppl; abstr 3600)), we performed subgroup analysis comparing the efficacy and safety between elderly (age ≥ 70 years, median 73 years, N = 245) and non-elderly ( < 70 years, median 57 years, N = 1,300) pts with advanced CRC or GC who received first- or second-line FOLFIRI chemotherapy. Results: In both CRC (N = 934) and GC cohorts (N = 611), elderly pts received significantly lower dose of irinotecan (CRC: mean 74.8% vs. 80.9%, P < 0.001; GC: 72.4% vs. 76.2%, P = 0.018) and infusional 5-fluorouracil (CRC: 61.6% vs. 71.8%, P < 0.001; GC: 47.1% vs. 55.8%, P = 0.004). However, the response rate was similar between elderly and non-elderly pts in both CRC (28.7% vs. 32.9%, P = 0.347) and GC cohorts (22.9% vs. 18.3%; P = 0.369). The progression-free survival was also similar between the two age groups in both CRC (median 27.9 vs. 29.1 weeks, P = 0.202) and GC cohorts (20.1 vs. 17.0 weeks, P = 0.407). In addition, the overall survival was comparable between the two age groups in both CRC (81.9 vs. 91.8 weeks, P = 0.965) and GC cohorts (33.6 vs. 49.3 weeks, P = 0.085). In both cohorts, asthenia was significantly more frequent in elderly pts, while nausea and vomiting were significantly more frequent in non-elderly pts. In CRC cohort, grade 3-4 toxicities that were significantly more frequent in elderly pts were asthenia (1.3% vs. 0.2% per cycle, P < 0.001), mucositis (0.4% vs. 0.1%, P = 0.021), and anorexia (0.8% vs. 0.2%, P = 0.005) in CRC cohort. However, in GC cohort, grade 3-4 toxicities were not significantly different between the two age groups. Conclusions: Despite relatively lower dose intensity in elderly pts, efficacy of FOLFIRI regimen in this subset was comparable to that of non-elderly pts. FOLFIRI regimen was relatively well tolerated in elderly pts. Taken together, FOLFIRI is a considerable standard backbone in elderly pts with advanced CRC or GC.

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Irinotecan Plus Mitomycin C as Second-Line Chemotherapy for Advanced Gastric Cancer Resistant to Fluoropyrimidine and Cisplatin: A Retrospective Study

Gastroenterology Research and Practice ◽

10.1155/2012/640401 ◽

2012 ◽

Vol 2012 ◽

pp. 1-5 ◽

Cited By ~ 1

Author(s):

Kohei Ogawa ◽

Ayumu Hosokawa ◽

Akira Ueda ◽

Seiko Saito ◽

Hiroshi Mihara ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Mitomycin C ◽

Median Overall Survival ◽

Overall Response Rate ◽

Progression Free Survival ◽

Second Line ◽

Free Survival ◽

Grade 3 ◽

Line Chemotherapy

Background. S-1 plus cisplatin has been established to be standard first-line chemotherapy for advanced gastric cancer in Japan. The optimal second-line treatment refractory to S-1 plus cisplatin remains unclear.Methods. We retrospectively studied the efficacy, toxicity, and survival of irinotecan plus mitomycin C in patients with advanced gastric cancer refractory to a fluoropyrimidine plus cisplatin.Results. Twenty-four patients were studied. Prior chemotherapy was S-1 plus cisplatin in 15 patients, S-1 plus cisplatin and docetaxel in 8, and 5-fluorouracil plus cisplatin with radiotherapy in 1. The overall response rate was 17.4%. The median overall survival was 8.6 months, and the median progression-free survival was 3.6 months. Grade 3 or 4 toxicities included leukopenia (33%), neutropenia (50%), anemia (33%), thrombocytopenia (4%), anorexia (13%), diarrhea (4%), and febrile neutropenia (13%).Conclusion. A combination of irinotecan and mitomycin C is potentially effective in patients with advanced gastric cancer refractory to a fluoropyrimidine plus cisplatin.

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Retrospective cohort study of nanoparticle albumin-bound paclitaxel plus ramucirumab versus paclitaxel plus ramucirumab as second-line treatment in patients with advanced gastric cancer

10.21203/rs.3.rs-26226/v3 ◽

2020 ◽

Author(s):

Mashiro Okunaka ◽

Daisuke Kotani ◽

Ken Demachi ◽

Akihito Kawazoe ◽

Takayuki Yoshino ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Progression Free Survival ◽

Similar Efficacy ◽

Hazard Ratio ◽

Line Treatment ◽

Second Line ◽

Efficacy And Safety ◽

Free Survival ◽

Grade 3

Abstract Background: Nanoparticle albumin-bound paclitaxel (nab-PTX) has shown non-inferiority to paclitaxel (PTX) as second-line therapy for advanced gastric cancer (AGC) with fewer infusion-related reactions. The efficacy and safety of nab-PTX plus ramucirumab (RAM) was reported in a phase II trial; however, there is no randomized trial comparing this regimen with PTX plus RAM in patients with AGC. This retrospective study aimed to investigate the efficacy and safety of nab-PTX plus RAM versus PTX plus RAM in patients with AGC.Methods: This study included patients with AGC who received nab-PTX plus RAM from September 2017 to January 2019 or PTX plus RAM from June 2015 to August 2017 as second-line chemotherapy in our hospital.Results: A total of 113 and 138 patients who received nab-PTX plus RAM and PTX plus RAM, respectively, were analyzed. Median progression-free survival (PFS) was 3.9 months (95% confidence interval [CI]: 3.4–4.3) in the nab-PTX plus RAM group and 3.9 months (95% CI: 3.1–4.7) in the PTX plus RAM group (hazard ratio [HR]: 1.08; 95% CI: 0.83–1.40; P = 0.573). Median overall survival (OS) was 10.9 months (95% CI: 9.3–12.7) in the nab-PTX plus RAM group and 10.3 months (95% CI: 8.5–12.0) in the PTX plus RAM group (hazard ratio: 0.82; 95% CI: 0.61–1.10; P = 0.188). In patients with moderate/massive ascites, favorable outcomes for progression-free survival were observed in the nab-PTX plus RAM group compared with the PTX plus RAM group. Although anemia and fatigue (any grade) were more frequent in the nab-PTX plus RAM group, discontinuation of study treatment was not increased in the nab-PTX plus RAM group. There was no occurrence of hypersensitivity reaction in the nab-PTX plus RAM group, while two patients (1.4%) experienced grade 3 hypersensitivity reactions in the PTX plus RAM group.Conclusions: The combination of nab-PTX plus RAM showed a similar efficacy and safety profile to PTX plus RAM as second-line treatment for patients with AGC.

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Phase II trial of S-1 plus split cisplatin (SSP) in patients with advanced gastric cancer (HGCSG0702): Final report.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.3_suppl.113 ◽

2014 ◽

Vol 32 (3_suppl) ◽

pp. 113-113

Author(s):

Satoshi Yuki ◽

Yoshito Komatsu ◽

Hiraku Fukushima ◽

Takahide Sasaki ◽

Yoshimitsu Kobayashi ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Phase Ii ◽

Response Rate ◽

Phase Ii Trial ◽

Performance Status ◽

Dose Intensity ◽

Progression Free Survival ◽

Final Report ◽

Free Survival

113 Background: On the basis of SPIRITS trial, S-1 plus cisplatin has been regarded as standard first-line chemotherapy for patients with advanced gastric cancer (AGC) in Japan (Koizumi W, et al. Lancet Oncol, 2008). However, conventional S-1 plus cisplatin (60mg/m2) regimen requires hospitalization for hydration. Therefore, we conducted phase II trial of S-1 plus split Cisplatin (SSP) for outpatient chemotherapy. Methods: Eligibility criteria included pathologically confirmed AGC; no prior chemotherapy; Age 20 to 75, ECOG performance status (PS) of 0 to 1; adequate organ function; and written informed consent. S-1 (40 mg/m2) was given orally, twice daily for 21 days, and cisplatin (30 mg/m2) was given intravenously on day 1 and 15, followed by 2-week rest period, within a 5-week cycle. Primary endpoint was the response rate (RR), and secondary endpoints were progression-free survival, overall survival, safety profile, and non-hospitalized survival. Results: Between Mar 2008 and Mar 2012, 40 pts were enrolled. Patients characteristics were as follows: median age 63 years (range 41-75), Male: female 30:10, PS 0:1 33:7, diffuse: intestinal 23:17. Median number of cycles was 3. The main grade 3-4 AE were neutropenia (37.5%), anemia (30%), anorexia (30%) and fatigue (15%). These toxicities were safely managed. The median relative dose intensity of S-1 was 0.782, and cisplatin was 0.824. Response rate was 57.5% (95%CI 42.2-72.8%) and disease control rate was 90.0%. Median progression-free survival was 6.1 months (95%C.I. 3.0-9.1 months) and median survival time was 15.8 months (95%C.I. 12.7-18.8 months). Conclusions: SSP showed comparable tolerability and efficacy to SPIRITS trial. In addition, most patients underwent the treatment without hospitalization. SSP may be one of practical alternatives for AGC.

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Phase II study of S-1 plus docetaxel as first-line treatment for elderly patients with advanced gastric cancer (OGSG0902).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.129 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. 129-129

Author(s):

Jin Matsuyama ◽

Hiroshi Imamura ◽

Ryohei Kawabata ◽

Tomono Kawase ◽

Kazuyuki Okada ◽

...

Keyword(s):

Gastric Cancer ◽

Elderly Patients ◽

Survival Time ◽

Advanced Gastric Cancer ◽

Response Rate ◽

Progression Free Survival ◽

Line Treatment ◽

First Line ◽

Free Survival ◽

First Line Treatment

129 Background: There is not enough evidence for the treatment of elderly patients with advanced gastric cancer. S-1 plus CDDP is one of the standard treatment for advanced gastric cancer in japan, but the efficacy remains insufficient due to the drug toxicity such as renal function disorders. The efficacy and safety of S-1 plus docetaxel as first-line treatment for elderly patients with unresectable advanced or recurrent gastric cancer were investigated. Methods: 75 years or older patients with unresectable advanced or recurrent gastric cancer were enrolled. Docetaxel was administered i.v. (40mg/m2) on day 1, while S-1 was administered orally (80mg/m2/day, b.i.d.) for 14 days followed by a 7-day rest. This schedule was repeated every 3 weeks. The primary endpoint was response rate (RR) of S-1 plus docetaxel; secondary endpoints were safety, progression free survival (PFS), time to treatment failure (TTF) and overall survival (OS). Sample size was set to be 30, which was determined to reject the response rate of 20% under the expectation of 40% with the power of 90% and two-sided alpha of 5%. Results: 31 patients were enrolled and assessable for efficacy. The response rate was 45.2% (95%CI 27.3-64.0, p = 0.001), and disease control rate was 77.4%. The median progression-free survival time was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1months. In 31 patients assessed for safety, the major grade 3/4 toxic effects were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%). Conclusions: These findings indicate that S-1 plus docetaxel as first-line treatment for elderly patients is feasible and shows promising efficacy against advanced gastric cancer. Clinical trial information: UMIN000002785.

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