Phase II study of docetaxel (DTX) and S-1 as neoadjuvant chemotherapy for potentially R0 advanced gastric cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 74-74
Author(s):  
Yasunori Emi ◽  
Eiji Oki ◽  
Hiroshi Saeki ◽  
Masaru Morita ◽  
Tetsuya Kusumoto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Preoperative Chemotherapy ◽  
Curative Resection ◽  
Response Rate ◽  
Clinical Stage ◽  
Preoperative Staging ◽  
Peritoneal Cytology ◽  
Eligibility Criteria

74 Background: This trial sought to evaluate the efficacy and safety of preoperative chemotherapy with DTX plus S-1 for advanced gastric cancer with poor prognosis even after R0 curative resection. We show the 2 years follow-up data. Methods: Preoperative staging was confirmed by laparoscopy. Eligibility criteria included 1) negative peritoneal cytology, H0, P0 and M0, 2) possible curative resection, and 3) ECOG PS 0-1. Patients received DTX (35 mg/m2) on days 1 and 15, and daily oral administration of S-1 (80 mg/m2/day) for days 1–14 every 4 weeks of 2 courses, followed by gastrectomy with D2 lymphadenectomy. The primary endpoint was pathological response rate (pRR). A sample size of 45 was planned for the expected pRR of 40% and threshold value of 20%, with one-sided alpha of 0.05 and beta of approximately 0.1. Results: A total of 47 patients were centrally registered between November 2007 and November 2009 from 14 centers. All patients were eligible for analysis. The median age was 63 (range 37–79); male/female: 36/11; PS0/1:41/6; and clinical stage IIIA/IIIB: 31/16. The target pRR was 47% (90%CI, 34–60%; p<0.0001). Forty six patients (98%) underwent surgery, in whom curative resection was performed in 44 patients, and 37 patients completed the protocol treatment. The response to preoperative chemotherapy was PR/SD/PD/NE in 16/24/2/5 with a response rate of 34%. The rate of 2 years and 3 years DFS were 53.9%, and 49.3%, respectively. The rate of 2 years and 3 years Overall survival were 69.6%, and 55.1%, respectively. The most common toxicities of neoadjuvant chemotherapy were grade 3/4 neutropenia (42%), febrile neutropenia (4%), grade 2 anorexia (21%), and fatigue (15%). Major operative morbidity included pancreatic fistula (9%), abdominal abscess (11%), pneumonia (2%), and anastomotic leakage (0%). No patients died due to surgical complications. Conclusions: The combination of DTX and S-1 was well tolerated and promising as a preoperative chemotherapy regimen for patients with potentially resectable advanced gastric cancer. Clinical trial information: UMIN000000875.

Phase II study of docetaxel (DTX) and S-1 as neoadjuvant chemotherapy for potentially R0 advanced gastric cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 106-106
Author(s):  
M. Watanabe ◽  
Y. Emi ◽  
Y. Kakeji ◽  
E. Oki ◽  
Y. Sakaguchi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Preoperative Chemotherapy ◽  
Curative Resection ◽  
Response Rate ◽  
Clinical Stage ◽  
Preoperative Staging ◽  
Peritoneal Cytology ◽  
Grade 3

106 Background: This trial sought to evaluate the efficacy and safety of preoperative chemotherapy with DTX plus S-1 for advanced gastric cancer with poor prognosis even after R0 curative resection. Methods: Preoperative staging was confirmed by laparoscopy. Eligibility criteria included 1) negative peritoneal cytology, H0, P0 and M0, 2) possible curative resection, and 3) ECOG PS 0-1. Patients received DTX (35 mg/m2) on days 1 and 15, and daily oral administration of S-1 (80 mg/m2/day) for days 1–14 every 4 weeks of 2 courses, followed by gastrectomy with D2 lymphadenectomy. The primary endpoint was pathological response rate (pRR), which was defined as degeneration occupying more than one-third of the cross-sectional surface area of the tumor. A sample size of 45 was planned for the expected pRR of 40% and threshold value of 20%, with one-sided alpha of 0.05 and beta of approximately 0.1. This study was registered in the UMIN clinical trial registry (UMIN000000875). Results: A total of 47 patients were centrally registered between November 2007 and November 2009 from 14 centers. All patients were eligible for analysis. The median age was 63 (range 37–79); male/female: 36/11; PS0/1:41/6; and clinical stage IIIA/IIIB: 31/16. The target pRR was 47% (90% CI, 34–60%; p < 0.0001). Forty six patients (98%) underwent surgery, in whom curative resection was performed in 44 patients, and 37 patients completed the protocol treatment. The response to preoperative chemotherapy was PR/SD/PD/NE in 16/24/2/5 with a response rate of 34%. The most common toxicities of neoadjuvant chemotherapy were grade 3/4 neutropenia (42%), febrile neutropenia (4%), grade 2 anorexia (21%), and fatigue (15%). Seven did not complete the neoadjuvant therapy due to 2 allergic reaction, 1 grade 3 anorexia, 2 grade 2 nausea and anorexia, 2 PD (all 7 had gastrectomy). Major operative morbidity included pancreatic fistula (9%), abdominal abscess (11%), pneumonia (2%), and anastomotic leakage (0%). No patients died due to surgical complications. Conclusions: The combination of DTX and S-1 was well tolerated and promising as a preoperative chemotherapy regimen for patients with potentially resectable advanced gastric cancer. [Table: see text]

Long-term outcomes of preoperative chemotherapy with modified DCS therapy for highly advanced gastric cancer with distant metastasis.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 193-193
Author(s):  
Atsushi Matsuki ◽  
Atsushi Nashimoto ◽  
Hiroshi Yabusaki ◽  
Masaki Aizawa
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Preoperative Chemotherapy ◽  
Distant Metastasis ◽  
Response Rate ◽  
Performance Status ◽  
Pathological Response ◽  
Morbidity Rate ◽  
R0 Resection ◽  
Eligibility Criteria

193 Background: Among patients (pts) with advanced gastric cancer (AGC), the poor prognosis was exhibited and many pts died even after R0 resection. The aim of this study is to evaluate the preoperative chemotherapy with docetaxel, cisplatin and S-1 (modified DCS therapy) for treatment in highly AGC with distant metastasis. Methods: A retrospective analysis was performed in 58 pts (man/woman; 49/9, median age; 64.5-years) treated with preoperative modified DCS therapy in our hospital between 2009 and 2012. Eligibility criteria included StageIV AGC with distant metastasis (H1;14, P1;18,CY1;31, LYM;25, PUL;2, OTH;2), a Performance status of 0-2 and no prior chemotherapy. The regimen consisted of docetaxel and cisplatin infusion (35mg/m2, days 1 and 15) and oral administration of S-1 (80mg/m2, days 1-14) every 4 weeks. Surgery was planned 3 to 4 weeks after the chemotherapy. Pathological response was graded according to the JGCA criteria. Almost all pts were treated with S-1 as postoperative adjuvant chemotherapy. Results: The median cycles was 2 (1-13). The incidence of grade 3/4 toxicity was neutropenia 53.4%, anemia 8.6%, anorexia 15.5%, nausea 5.2%, and diarrhea 3.4%. All of these toxicities were well tolerable and there was no TRD. According to RECIST, The overall response rate was 79.3%. Forty-tree pts underwent gastrectomy (R0/R1/R2; 27/8/8), respectively. Postoperative morbidity rate was 20.9% and there was no mortality. Over all 5 years survival rate (5YSR) was 21.4 % and that of R0 was 44.8%, on the other hand 5YSR and MST of chemotherapy alone was 0% and 14.5 month. Pathological response rate (>=1b) was 60.5% and complete response was achieved 1 pts. 5YSR of pathological responders who underwent R0 resection was 81.4% and that of non-responders who underwent even R0 resection was 22.5% (P<0.05). Conclusions: Preoperative modified DCS therapy for AGC was tolerable, and survival benefit of pathological responders with R0 surgery was promising and warrants further investigation.

Locally advanced gastric cancer treated with neoadjuvant chemotherapy: Epirubicin, oxaliplatin, and capecitabine (EOX).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 136-136
Author(s):  
U. Pluschnig ◽  
J. Zacherl ◽  
S. Schoppmann ◽  
M. Raderer ◽  
G. Prager ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Disease Progression ◽  
Advanced Gastric Cancer ◽  
Preoperative Chemotherapy ◽  
Locally Advanced ◽  
Treatment Schedule ◽  
Gi Tract ◽  
Upper Gi ◽  
Upper Gi Tract

136 Background: Gastric cancer is a worldwide common malignant disease with a high mortality rate. Adjuvant chemotherapy did not result in a survival advantage in Caucasian populations. Therapeutic chemotherapy options consist of either monotherapy or of polychemotherapy and have been applied as neoadjuvant chemotherapy with combinations of epirubicin, cyclophosphamide and 5-fluorouracil or capecitabine as well as cisplatin or oxaliplatin. The aim of this retrospective analysis was to investigate the use of the EOX regimen in the neoadjuvant setting which had shown activity in advanced gastric cancer. Methods: 23 patients (pts) (median age: 70, range 36-85, years; 16 pts >65 years) with locally advanced adenocarcinoma of the upper GI-tract received 3 courses of preoperative chemotherapy with epirubicin 50 mg/m2, day1, oxaliplatin 130 mg/m2, day 1, and capecitabine 2,000 mg/m2, days 1-14, of a 3-week cycle. Toxicity was assessed by CTC (Common Toxicity Criteria) after every cycle. Progression free survival (PFS) was defined as time from surgery to disease progression assessed by PET-CT which was performed at diagnosis and after 3 cycles chemotherapy. Results: 20 pts completed all three planned cycles of preoperative chemotherapy, 2 pts received only 1 cycle because of rapid tumor progression and 1 pt. is currently still on treatment. 16 pts. underwent surgery with curative resection with 2 pCRs on pathological review. 6 pts. remained inoperable despite chemotherapy and 1 pt is currently scheduled for surgery. After surgery, 2 pts. died after a median of 9 months (8-10). 4 pts. died without surgery due to disease progression. After a median follow-up of eight months (range 5-26), median PFS and overall survival was not reached yet. In 2 pts., grade 3-4 toxicities including nausea, diarrhea and hand-foot syndrome and one non-life-threatening pulmonary embolism occurred. Conclusions: In summary, EOX is a well tolerated, safe, and efficacious neoadjuvant treatment in also elderly patients with locally advanced adenocarcinoma of the upper GI-tract. However, more studies with a larger population are needed to corroborate the current results of this promising treatment schedule. [Table: see text]

Multicenter phase II study of neoadjuvant chemotherapy consisted with S-1 and oxaliplatin followed by gastrectomy for locally advanced gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS180-TPS180
Author(s):  
Yoshihiro Okita ◽  
Hironaga Satake ◽  
Hiroyuki Okuyama ◽  
Masato Kondo ◽  
Akira Miki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Curative Resection ◽  
Locally Advanced ◽  
Nodal Involvement ◽  
Resection Rate ◽  
Locally Advanced Gastric Cancer ◽  
Large Type ◽  
Type 3

TPS180 Background: Prognosis for locally advanced gastric cancer, such as clinical T4 disease, bulky nodal involvement, type 4 and large type 3 gastric cancer, was not satisfactory even by D2 gastrectomy followed by adjuvant chemotherapy. Neoadjuvant chemotherapy is another promising approach. In our phase I study, neoadjuvant chemotherapy of S-1 and oxaliplatin (SOX) had manageable toxicities and good pathological complete response rate (33%) in patients with locally advanced gastric cancer. Based on the results of this phase I study, we initiate a multi-institutional, single-arm, open label, phase II study (Neo G-SOX PII study). The aim of this study is to evaluate the efficacy and safety of the neoadjuvant chemotherapy of S-1 and oxaliplatin (SOX) followed by gastrectomy with D2/3 lymph node dissection; clinical T4; clinically resectable gastric cancer of type 4 or large type 3 (over 8 cm); bulky nodal involvement around major branched arteries to the stomach Methods: Eligibility criteria include histologically proven adenocarcinoma of the stomach; clinical T4; clinically resectable gastric cancer of type 4 or large type 3 (over 8 cm); bulky nodal involvement around major branched arteries to the stomach; resectable peritoneal dissemination (pathological CY1 or P1, except for clinical CY1 or P1). Patients receive two cycles of neoadjuvant chemotherapy with S-1 (80 mg/m2, p.o., days 1-14 followed by 1 week rest) and oxaliplatin (130 mg/m2 at day 1), followed by D2 or higher surgery with no residual disease. Patients with pathological R0/1 resection received S-1 (80 mg/m2, p.o., days 1-28 followed by 2 week rest) for 1 year as adjuvant chemotherapy. Primary endpoint is curative resection rate. Key secondary endpoints include pathological response, R0/1 resection rate, dose-intensity, overall survival, relapse free survival and safety. We set the threshold curative resection rate at 65% and the expected curative resection rate at 80%. Given a one-sided α of 0.1 and statistical power of 80%, 40 patients was required. Clinical trial information: UMIN000018661 Clinical trial information: UMIN000018661.

Phase II trial of S-1 combined with oxaliplatin (SOX) as neoadjuvant chemotherapy for locally advanced gastric cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 122-122
Author(s):  
L. Chen
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
High Response Rate ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer

122 Background: Previous phase II trial with combination therapy of S-1 plus oxaliplatin (SOX) demonstrated high response rate and well tolerability in patients with untreated advanced gastric cancer. The aim of this phase II trial was to evaluate the efficacy and safety of SOX as neoadjuvant chemotherapy for locally advanced gastric cancer (AGC). Methods: Eligibility criteria included a histologically proven AGC with stage IIIb, IIIc (AJCC 7th edition), at least 1 measurable lesion, no prior chemotherapy, ECOG 0∼2, adequate hepatic, renal, and bone marrow function. Enrolled patients were staged by EUS and CT. The neoadjuvant chemotherapy consisted of 3-4 cycles of oxaliplatin (130 mg/m2) on day 1 and S-1 (80 mg/m2/day) for 14 days with 7 days rest. After chemotherapy, the patients underwent surgery. Results: From Dec 2009 to Sep 2010, 35 patients (IIIb; 19pts, IIIc; 16pts) were enrolled. The median age of the patients was 54.6 years (range; 20-72 y). All patients were available for evaluating the clinical responese and adverse events. The overall response rate was 68.5% (1CR, 23 PR, 9 SD, 2 PD). 32 patients underwent surgical resection. Of them, 27 patients underwent standard D2 surgery and 5 patients had palliative surgery. 25 patients had R0 resection. Postoperative pathological examination showed that most of the surgical patients were in T4a stage. According to Lauren classification, 71.9% patiens (23/32pts) were diffuse type, SOX showed higher respons rate (1CR, 20 PR, 2 SD, RR: 91.3%) among these patients. Major grade 3/4 hematological toxicities were anemia (5.7%), neutropenia (5.7%) and liver dysfunction (8.6%) and non-hematological toxicities were anorexia (5.7%) and vomiting (11.4%). But most of the adverse events were managable. Conclusions: Neoadjuvant chemotherapy with S-1 plus oxaliplatin (SOX) showed high response rate and and R0 resection rate for locally advanced GC, especially for diffuse type patients. All the patients did not have severe toxicity during the process of chemotherapy. This is the preliminary results, and the survival benefit in locally advanced GC patients that respond to SOX neoadjuvant chemotherapy needs to be addressed by a randomized-controlled trial. No significant financial relationships to disclose.

A phase ll study of trastuzumab in combination with triweekly S-1 plus CDDP in HER2-positive advanced gastric cancer (HERBIS-1).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 70-70 ◽  
Author(s):  
Naotoshi Sugimoto ◽  
Junji Tanaka ◽  
Masahiro Tsuda ◽  
Wataru Okamoto ◽  
Hiroyuki Okuda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Rapid Progression ◽  
Her2 Positive ◽  
Eligibility Criteria ◽  
Threshold Response ◽  
Esophagogastric Junction Adenocarcinoma ◽  
Ecog Ps ◽  
Measurable Lesion

70 Background: S-1, an oral fluoropyrimidine, plus cisplatin (SP) regimen is one of the standard chemotherapy as first-line for advanced gastric cancer (AGC). Although ToGA study demonstrated that trastuzumab (T-mab) in combination with capecitabine plus cisplatin or fluorouracil plus cisplatin improved the overall survival of patients (pts) with HER2-positive AGC, there was no study evaluating the efficacy and the safety of T-mab in combination with SP regimen. Methods: Eligibility criteria included gastric or esophagogastric junction adenocarcinoma; HER2-positive confirmed by IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive); unresectable or recurrent; measurable lesion; no history of chemotherapy or radiotherapy; age≤75; ECOG PS of 0-1; and adequate organ function. Pts received S-1 at 40–60 mg depending on body surface area, po bid, day 1-14, and cisplatin 60 mg/m2, iv, day 1, plus T-mab 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 assessed by the RECIST (ver 1.1). The planned sample size was 50 based on the threshold response rate of 35%, the expected rate of 50%, power of 80%, and 1-sided α of 0.1. Results: A total of 56 pts were enrolled from July 2011 to May 2012. Two pts were ineligible with inadequate renal function and no measurable lesion. Characteristics of 54 eligible pts were as follows: median age of 66 (range 34-75), M/F: 42/12, PS0/1: 42/12, unresectable/recuurent: 51/3, and IHC 2+/3+: 9/45. As one patient did not receive the protocol treatment due to the rapid progression of tumor, the efficacy and the safety analyses were conducted in the full analysis set of 53 pts. The confirmed response rate assessed by the independent review committee was 68%, and the disease control rate was 94%. The response rate without interval confirmation was 75%. The grade 3/4 adverse events (>5% of pts) were as follows: neutropenia 30%, leucopenia 8%, anorexia 21%, diarrhea 8%, hypoalbuminemia 8%, vomiting 6%, and increased creatinine 6%. Conclusions: T-mab in combination with triweekly SP regimen showed promising antitumor activity and manageable toxicities in pts with HER2-positiveAGC. Clinical trial information: UMIN000005739.

Updated analysis of HERBIS-1: A phase ll study of trastuzumab (T-mab) in combination with tri-weekly S-1 plus CDDP in HER2-positive advanced gastric cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 98-98
Author(s):  
Makio Gamoh ◽  
Naotoshi Sugimoto ◽  
Hiroto Miwa ◽  
Masahiro Tsuda ◽  
Shinichi Nishina ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Antitumor Activity ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Progression Free Survival ◽  
Event Analysis ◽  
Her2 Positive ◽  
Eligibility Criteria ◽  
Esophagogastric Junction Adenocarcinoma

98 Background: The HERBIS study demonstrated the promising antitumor activity and manageable toxicities of S-1 plus cisplatin and T-mab (SPT) regimen in patients (pts) with HER2-positive advanced gastric cancer (AGC) (Sugimoto et al. ASCO GI 2012, Abstract 70). We report the updated time-to event analysis. Methods: Main eligibility criteria were gastric or esophagogastric junction adenocarcinoma, HER2-positive, unresectable or recurrent, measurable lesion, no history of chemotherapy or radiotherapy, ECOG PS of 0-1 and adequate organ function. Pts received S-1(80-120mg / day) on days 1-14, cisplatin 60 mg/m2on day 1 and T-mab 8 mg/ kg on day 1 (6 mg/ kg from 2nd course) repeated every 3 weeks until disease progression. Primary endpoint was response rate (RR) and secondary endpoints were overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF) and adverse events. The planned sample size was 50 pts. Results: A total of 56 pts were enrolled from July 2011 to May 2012. Two pts were ineligible and one patient did not receive any treatment. Therefore, the efficacy and safety analyses were conducted in the full analysis set of 53 pts. The confirmed response rate was 67.9% (95% CI: 53.7-80.1), and the disease control rate was 94.3% (95% CI: 84.3-98.9). Median OS was 16.0 months (95% CI: 13.3 - NaN), median PFS was 7.8 months (95% CI: 6.0 – 8.8) and median TTF was 5.7 months (95% CI: 4.2 - 7.1), respectively at the median follow-up time of 13.5 months. The main grade 3/4 adverse events were leukopenia 8%, neutropenia 36%, anemia 15%, increased creatinine 6%, hypoalbuminemia 9%, anorexia 23%, diarrhea 8% and vomiting 6%. Conclusions: SPT have promising antitumor activity and manageable toxicities in pts with HER2-positive AGC. Clinical trial information: UMIN000005739.

Phase II study of combination therapy with docetaxel, cisplatin, and S-1 (DCS) for advanced gastric cancer: (KDOG 0601)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4555-4555
Author(s):  
N. Nakayama ◽  
W. Koizumi ◽  
T. Sasaki ◽  
S. Tanabe ◽  
K. Nishimura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Objective Response ◽  
High Response Rate ◽  
Ecog Performance Status ◽  
Eligibility Criteria

4555 Background: Our previous phase I study (Oncology 2008, 75:1–7) provided evidence that combination chemotherapy with docetaxel, cisplatin, and S-1 (DCS) is effective and well tolerated in patients with advanced gastric cancer. The present multicenter phase II study was conducted to confirm the efficacy and toxicity of DCS in advanced gastric cancer. Methods: Eligibility criteria included a histologically proved diagnosis of gastric adenocarcinoma with at least one measurable metastatic lesion, no previous treatment for gastric cancer except for surgery, an ECOG performance status of 0 to 2, and adequate organ function. Docetaxel (40 mg/m2) and cisplatin (70–60 mg/m2) were given intravenously on day 1, and S-1 was given orally at a dose of 40 mg/m2 twice daily from days 1 to day 14 of a 28-day cycle. Patients received a maximum of 6 cycles. Subsequently, patients were given repeated cycles of S-1 plus docetaxel (DS). The primary endpoint was the objective response rate. Results: 59 patients (47 men, 12 women) were enrolled. The median age was 62 (range: 35–75) years. PS 0/1/2 was 40/18/1. The median number of treatment cycles was 7 (DCS 6+DS 1: range, 1–20). Because myeloid suppression and renal dysfunction developed during the study, we lowered the recommended dose of cisplatin from 70 mg/m2 to 60 mg/m2. The dose of cisplatin was 70 mg/m2 in 19 patients and 60 mg/m2 in 40. The overall response rate was 81.3% (48/59; 95% CI, 80.7–91.2). The response rates with cisplatin 70 mg/m2 and 60 mg/m2 were 78.9% (95% CI, 60.5–97.2) and 82.5% (95% CI, 70.7–94.2), respectively. Tumor down-staging was achieved in 9 (18.7%) of the 48 patients who responded to treatment. The median survival time and median progression-free survival were not reached. Grade 3 or 4 major toxicity comprised leukopenia (44.0%), neutropenia (72.8%), anemia (15.2%), febrile neutropenia (13.5%), anorexia (6.7%), nausea (5.1%), vomiting (5.1%), fatigue (1.6%), and diarrhea (5.1%). There was one treatment-related death caused by the perforation of the primary tumor. This patient refused surgery. Conclusions: DCS was a well-tolerated regimen with a high response rate in patients with advanced gastric cancer. Cisplatin at a dose of 60 mg/m2 was considered adequately effective. No significant financial relationships to disclose.

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