Phase II study of S-1 in combination with paclitaxel as a first-line treatment for patients with advanced/recurrent gastric cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15615-e15615
Author(s):  
U. Toh ◽  
H. Yamana ◽  
K. Koufuji ◽  
T. Mine ◽  
K. Aoyagi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Single Agent ◽  
First Line ◽  
Curative Gastrectomy ◽  
Intention To Treat ◽  
Recurrent Gastric Cancer ◽  
Grade 3 ◽  
Treat Analysis

e15615 Background: Taxanes and S-1 have been shown to be effective in patients with advanced gastric cancer and they have a considerable single-agent activity, respectively. We evaluated the combination of paclitaxel and S-1 as first-line chemotherapy for advanced or recurrent gastric cancer (AGC). Methods: All patients with histologically confirmed AGC with unresectable or metastatic diseases, measurable lesions, PS 0–2, age between 18 and 75, and no contraindication to chemotherapy were eligible in this study. Prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. Treatment included S-1 80 mg/m2 p.o. twice daily on days 1–14 and paclitaxel 60 mg/m2 i.v. on day 1, 8, 15 with a 2-week interval until disease progression or unacceptable toxicities. Results: Between MAY 2004 and Match 2008, total 20 pts were enrolled in this study. The median age was 56.5 years (range, 38–73). Nine pts had recurrent disease after previous curative gastrectomy and 8 had previous adjuvant chemotherapy. After a median 4 (range, 1–9) cycles of chemotherapy, 12 pts were evaluable for toxicity and 20 pts for response. In intention-to-treat analysis, the overall response rate was 62.9% (95% C.I., 36.2–69.6%), including 0 CR, 6 PRs, 8 SDs, and 6 PDs. After a median follow-up of 8.6 months (range, 0.9–17.9), median time to progression was 6.3 months (95% C.I., 3.6–6.9) and median overall survival was 11.6 months (95% C.I., 8.5–20.7). Commonly observed grade 3/4 adverse events were neutropenia (40% of patients), anemia (10%). There was no neutropenic fever or treatment-related death. Conclusions: The combination of paclitaxel and S-1 appear to have well efficacy, manageable toxicity and is well tolerated in patients with AGC. Further studies of this combination should be considered. No significant financial relationships to disclose.

Multicenter phase II study of docetaxel plus oxaliplatin combination chemotherapy in patients with advanced gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15026-15026
Author(s):  
J. Kim ◽  
H. Song ◽  
Y. Do ◽  
K. Lee ◽  
M. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Median Overall Survival ◽  
Combination Regimen ◽  
Intention To Treat ◽  
Patient Refusal ◽  
Grade 3 ◽  
Treat Analysis ◽  
Unacceptable Toxicity

15026 Background: The present study was conducted to evaluate the efficacy and safety of a combination regimen of docetaxel plus oxaliplatin in patients with advanced gastric cancer. Methods: Patients with previously untreated metastatic or recurrent, measurable gastric cancer received intravenous docetaxel 65 mg/m2 plus oxaliplatin (Oxalpla®, Yuhan.Co. Seoul, Korea) 120 mg/m2 on days 1 in a 3-week cycle. Treatment was continued until disease progression, patient refusal, or an unacceptable toxicity up to 9 cycles. Results: Forty-two patients were enrolled in the current study. Of these, 39 were assessable for efficacy and 41 assessable for toxicity. Seventeen partial responses were confirmed, giving an overall response rate of 40.5% (95% CI: 26.0% to 54.1%, intention-to-treat analysis). At a median follow-up of 160.5 days, the median time to progression was 6.1 months, whereas median overall survival was not reached yet. Grade 3/4 neutropenia occurred in 10 patients, plus febrile neutropenia was observed in 3 patients. Most common non-hamatologic toxicity was nausea (grade 1/2 56.9%). There were two treatment-related deaths. Conclusions: Docetaxel and oxaliplatin combination was found to be well-tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer. No significant financial relationships to disclose.

Feasibility of sequential fixed S-1 followed by paclitaxel for the treatment of advanced or recurrent gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15113-15113
Author(s):  
M. Ohashi ◽  
T. Kanda ◽  
K. Yajima ◽  
H. Honma ◽  
S. Kosugi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Treatment Time ◽  
Performance Status ◽  
Single Agent ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Recurrent Gastric Cancer ◽  
Line Chemotherapy

15113 Background: First-line chemotherapy for advanced/recurrent gastric cancer has limited efficacy, achieving a median survival time (MST) of about 7 months, while addition of second-line and subsequent chemotherapy may prolong MST to about 11.5 months. In practice, however, about half of patients failing with first-line chemotherapy are unable to receive second-line chemotherapy because of worsening of their performance status (PS), disease progression, or toxicities during protracted first-line chemotherapy. We studied the feasibility of a sequential fixed regimen devised to ensure prompt initiation of second-line chemotherapy after first-line failure. Methods: Between December 2002 and December 2006, patients with advanced or recurrent gastric cancer were enrolled who met the following requirements: 1) major organ function preserved; 2) PS 0–2; 3) presence of at least one evaluable lesion; and 4) written informed consent. The treatment regimen consisted of 3 courses of single-agent S-1 or S-1/cisplatin combination followed by weekly paclitaxel (wPTX). The endpoints of the study were entry to the second-line treatment, time to failure (TTF), and MST. Results: Of 39 patients enrolled, 37 completed first- line S-1. Twenty-eight patients (76%) then received wPTX, 2 non-wPTX chemotherapy, and 6 surgery; only 1 received no additional treatments. Second-line wPTX was followed by a third-line treatment in 23/28 patients (82%). The TTF with the sequential fixed regimen was 7 months. The MST and the 1- and 2-year survival rates in the 37 completing first-line treatment were 14.6 months, 61% and 25%, while those in the 28 switched over to wPTX were 12.5 months, 51% and 17%. Conclusions: Patients with advanced/recurrent gastric cancer treated sequentially with a fixed number of courses of S-1 followed by wPTX may have a good chance of treatment continuation. A sequential fixed regimen may further improve survival of patients with advanced/recurrent gastric cancer only with combinations of currently available drugs. No significant financial relationships to disclose.

Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14037-14037
Author(s):  
J. Baek ◽  
J. Kim ◽  
Y. Chae ◽  
Y. Cho ◽  
S. Sohn ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Combination Chemotherapy ◽  
Overall Response Rate ◽  
Combination Regimen ◽  
Time To Progression ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Grade 3

14037 Background: Several studies have shown the efficacy of capecitabine and irinotecan combination chemotherapy for advanced colorectal cancer, while no results have yet been reported for advanced gastric cancer. Accordingly, the current study evaluated the efficacy and safety of a combination regimen of capecitabine plus irinotecan in patients with advanced gastric cancer. Methods: Patients with previously untreated metastatic or recurrent, measurable gastric cancer received oral capecitabine 1000 mg/m2 twice daily from day 1 to 14 and intravenous irinotecan 100 mg/m2 on days 1 and 8, based on a 3-week cycle. Results: Forty-one patients were enrolled in the current study, among whom 38 were assessable for efficacy and 40 assessable for toxicity. Three complete responses and 16 partial responses were confirmed, giving an overall response rate of 46.3%. At a median follow-up of 269 days, the median time to progression and overall survival were 5.1 months and 8.6 months, respectively. Grade 3/4 neutropenia occurred in 4 patients and grade 3 febrile neutropenia was observed in 2 patients. Grade 3 diarrhea and grade 2 hand-foot syndrome occurred in 6 patients and 8 patients, respectively. Conclusions: The combination of capecitabine and irinotecan was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer. No significant financial relationships to disclose.

Effect of S-1 Adjuvant Chemotherapy on Survival following Recurrence and Efficacy of First-Line Treatment in Recurrent Gastric Cancer

Chemotherapy ◽  
2010 ◽  
Vol 56 (6) ◽  
pp. 436-443 ◽  
Author(s):  
Hiroko Hasegawa ◽  
Kazumasa Fujitani ◽  
Yukinori Kurokawa ◽  
Motohiro Hirao ◽  
Shoichi Nakazuru ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Line Treatment ◽  
First Line ◽  
Recurrent Gastric Cancer ◽  
First Line Treatment

scholarly journals Phase II feasibility study of adjuvant chemotherapy with docetaxel/cisplatin/S-1 followed by S-1 for stage III gastric cancer

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Noriyuki Hirahara ◽  
Takeshi Matsubara ◽  
Shunsuke Kaji ◽  
Tetsu Yamamoto ◽  
Ryoji Hyakudomi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Rest Period ◽  
Dose Intensity ◽  
Stage Iii ◽  
Postoperative Treatment ◽  
Hematological Toxicity ◽  
Curative Gastrectomy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Abstract Background This study aimed to evaluate the feasibility, safety, and efficacy of postoperative adjuvant chemotherapy with docetaxel/cisplatin/S-1 (DCS) following S-1 therapy in patients with stage III gastric cancer after curative gastrectomy. Methods Patients with stage III gastric cancer who underwent D2 gastrectomy were enrolled. Adjuvant chemotherapy was initiated within 8 weeks of gastrectomy. The first cycle of chemotherapy consisted of S-1 monotherapy (day 1–14), followed by a 7-day rest period. Cycles 2 and 3 consisted of the following: S-1 (day 1–14) administration, followed by a 14-day rest period, and an intravenous infusion of cisplatin and docetaxel on days 1 and 15. After two cycles, S-1 was administered for up to 1 year. Results Thirty patients were enrolled between 2014 and 2017. Febrile neutropenia of grade 3 or higher was the most common hematological toxicity with 4 patients (13.3%). Other hematological toxicities of grade 3 or higher were as follows: neutropenia in 3 (10.0%), leukopenia in 3 (10.0%), and anemia in 2 (6.7%) patients. Most frequent non-hematological toxicity of grade 3 was anorexia (n = 4, 13.3%) and general fatigue (n = 3, 10.0%); no grade 4 non-hematological toxicities were observed. Twenty-five patients (83.3%) completed two cycles of DCS treatment and 18 (60.0%) completed subsequent S-1 treatment for 1 year. The relative dose intensity of docetaxel and cisplatin was 0.86 and that of S-1 was 0.88. Conclusion The DCS regimen can be acceptable as an adjuvant chemotherapy and offers an effective postoperative treatment option for stage III gastric cancer patients. Trial registration number UMIN000012785. Date of registry 08/01/2014.

A Phase III PETHEMA/GEM Randomized Trial of Postransplant (ASCT) Maintenance in Multiple Myeloma: Superiority of Bortezomib/Thalidomide Compared with Thalidomide and Alfa-2b Interferon,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3962-3962 ◽  
Author(s):  
Laura Rosiñol ◽  
María Teresa Cibeira ◽  
Maria Victoria Mateos ◽  
Joaquin Martinez ◽  
Albert Oriol ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Single Agent ◽  
Phase Iii ◽  
Hematological Toxicity ◽  
Advisory Committees ◽  
Intention To Treat ◽  
Maintenance Program ◽  
Response Status ◽  
Grade 3

Abstract Abstract 3962 Introduction: In April 2006, the Spanish Myeloma Group (PETHEMA/GEM) activated a randomized phase III trial comparing induction with TD vs. VTD vs. VBMCP/VBAD/Bortezomib (VBMCP/VBAD/B) in patients 65 years-old or younger with newly diagnosed symptomatic MM and ASCT with MEL-200 followed by maintenance with thalidomide/bortezomib (TV) vs. thalidomide (T) vs. alfa-2b-interferon (alfa2-IFN). Primary end points : response rate after induction and after ASCT and time to progression. Patients and Methods: The maintenance program consisted of TV (thalidomide 100 mg daily plus one cycle of bortezomib-1.3 mg/m2 on days 1, 4, 8 and 11 every 3 months) versus T (single agent thalidomide at a dose of 100 mg daily) versus alfa2-IFN (subcutaneous alfa2b-IFN at a dose of 3 MU three times per week). The planned maintenance duration was three years or until disease progression or toxicity. From February 1, 2007 to January 27, 2011 266 patients were randomized to maintenance therapy (TV:90; T: 89, alfa2-IFN: 87). Response and survival were evaluated on an intention-to-treat basis. Responses and progressions reported by the investigators were centrally reassessed. Results: the patient's characteristics at diagnosis such as age, ISS stage, cytogenetics and presence of extramedullary plasmacytomas as well as induction regimen (VTD, TD and VBMCP/VBAD/Bortezomib) and diagnosis-randomization interval were similarly distributed among the 3 arms. The response status at the time of randomization after ASCT was CR: 51%, VGPR: 23%, PR: 24% and SD: 2% and was well balanced in the three groups. The CR rate with maintenance was improved by 23% with TV, 11% with T and 19% with alfa2-IFN (p=NS). After a median follow-up of 24 months, the PFS was significantly longer with TV compared with T and alfa2-IFN (PFS at 2 yrs: 78% vs. 63% vs. 49%, p=0.01). However, OS was not significantly different among the 3 arms. Grade 3 and 4 hematological toxicity was similar (22.2% vs. 16% vs. 21.8%). No peripheral neuropathy (PN) was observed with alfa2-IFN being its frequency similar with TV (12.2%) and T (10.1%). No grade IV PN was observed. Dose reductions for TV, T and alfa2-IFN were required in 33.3%, 33.7% and 19.5% of the patients, respectively. The discontinuation rate due to toxicity was significantly higher with thalidomide compared with TV (30.3% vs. 15.6%, p= 0.08) and with alfa2-IFN (30.3% vs. 18.3%, p= 0.17). Conclusion: the addition of bortezomib to thalidomide maintenance resulted in a significantly longer PFS when compared with thalidomide alone or with IFN with no increased toxicity. Disclosures: Rosiñol: Janssen: Honoraria; Celgene: Honoraria. Cibeira:Janssen: Honoraria; Celgene: Honoraria. Mateos:Janssen: Honoraria; Celgene: Honoraria. Martinez:Janssen: Honoraria; Celgene: Honoraria. de la Rubia:Janssen: Honoraria; Celgene: Honoraria. Díaz-Mediavilla:Janssen: Honoraria; Celgene: Honoraria. Alegre:Janssen: Honoraria; Celgene: Honoraria. Lahuerta:Janssen: Honoraria; Celgene: Honoraria. San Miguel:Millennium Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Blade:Janssen: Honoraria; Celgene: Honoraria.

Overall survival and independent review of response in CheckMate 214 with 42-month follow-up: First-line nivolumab + ipilimumab (N+I) versus sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 609-609 ◽  
Author(s):  
Nizar M. Tannir ◽  
David F. McDermott ◽  
Bernard Escudier ◽  
Hans J. Hammers ◽  
Osvaldo Rudy Aren ◽  
...  
Keyword(s):  
Clear Cell ◽  
Complete Response ◽  
Review Committee ◽  
First Line ◽  
Intention To Treat ◽  
Independent Review ◽  
Grade 3 ◽  
Clinical Trial Information ◽  
Over Time

609 Background: N+I demonstrated superior OS and ORR v S in intention-to-treat (ITT) and intermediate/poor-risk (IP) pts with aRCC in CheckMate 214. Here, we report OS, response outcomes per independent radiology review committee (IRRC), and safety with extended min follow-up of 42 mo. Methods: Pts with clear cell aRCC were randomized 1:1 to N 3 mg/kg + I 1 mg/kg Q3W×4 and then N 3 mg/kg Q2W, or S 50 mg daily for 4 wk on, 2 wk off. Endpoints were OS, ORR, and PFS per IRRC using RECIST v1.1 in IP (primary), ITT (secondary), and favorable pts (FAV; exploratory). Results: OS remained superior in ITT (HR 0.72) and IP (HR 0.66) pts with N+I v S (Table). ORR per IRRC was higher and more responses were ongoing with N+I v S (68% v 53% [ITT] and 68% v 52% [IP]). More pts achieved complete response (CR) with N+I and these were ongoing in 86% [ITT] and 84% [IP] of pts. The PFS probability with N+I stabilized after 24 mo at ~35% in ITT and IP pts, whereas probabilities declined over time with S. Among FAV pts, while ORR was 29% with N+I v 54% with S, more pts achieved CR (13% v 6%), and more responses were ongoing (69% v 54%) with N+I v S; 94% of CRs in FAV pts were ongoing with N+I. OS benefits were similar in both arms and PFS probabilities are stabilizing with N+I and declining with S in FAV pts. The incidence of any and grade 3–4 treatment-related AEs was consistent with previous reports and no new drug-related deaths occurred in either arm. Response outcomes per investigator will also be reported. Conclusions: Superior OS and ORR with N+I v S was maintained in ITT and IP pts. More pts treated with N+I experienced CR compared with S, responses and CRs were durable, and PFS probabilities stabilized with N+I after extended follow-up. No new safety signals emerged. Clinical trial information: NCT02231749 .[Table: see text]

Phase II clinical trial of XELOX as first line treatment for patients with unresectable or metastatic gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15062-15062
Author(s):  
R. Xu ◽  
B. Han ◽  
Y. Shi ◽  
J. Xiong ◽  
Y. Li ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Objective Response ◽  
Metastatic Gastric Cancer ◽  
Line Treatment ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
First Line Treatment

15062 Background: The survival of advanced gastric cancer remains poor, while no chemotherapy regimen was recognized standard. Oxaliplatin and Capecitabine (Xeloda) have demonstrated promising antitumor efficacy in advanced colorectal cancer. The present study was conducted to further evaluate the efficacy and safety of XELOX (Oxaliplatin and Xeloda) regimen in gastric cancer. Methods: Patients with unresectable or metastatic gastric cancer were enrolled into this study. They all receive the XELOX regimens (Oxaliplatin 130mg/ m2 intravenously in 2 hours on day 1 followed by oral capecitabine 1000mg/ m2 twice daily for 14 days every 3 weeks).We evaluated the response every 2 cycles. Results: The median age of the total enrolled 45 patients was 55 years (range, 22–82 years), including 32 male and 13 female. They received a median of 5 cycles (range, 2–8 cycles) of XELOX. 21 of 45 patients (46.7%) achieved an objective response, 1 patient (2.2%) had completed response. 17 patients (37.8%) experienced stable disease. Median time to tumor progression (TTP) and median overall survival were not available yet due to the further follow-up needed. Most toxicity events were mild to moderate in XELOX regimen, with grade 3/4 neutropenia of 8.9 %, thrombocytopenia of 6.7%, anemia of 11.1%, hand-foot syndrome of 6.7 % and diarrhea of 6.7 %. Grade 3 neuropathy was 4.4%. The patients with advanced gastric cancer had a good tolerance to this chemotherapy. Conclusions: XELOX is a highly effective first-line treatment for unrsectable and metastatic gastric cancer. The response rates in this trial seems to be similar to those observed with FU/leucovorin/oxaliplatin combinations. XELOX is tolerable well in the treatment of advanced gastric cancer. No significant financial relationships to disclose.

scholarly journals Phase II Feasibility Study of Adjuvant Chemotherapy With Docetaxel/Cisplatin/S-1 Followed By S-1 For Stage III Gastric Cancer

2021 ◽  
Author(s):  
Noriyuki Hirahara ◽  
Takeshi Matsubara ◽  
Shunsuke Kaji ◽  
Tetsu Yamamoto ◽  
Ryoji Hyakudomi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Rest Period ◽  
Dose Intensity ◽  
Stage Iii ◽  
Postoperative Treatment ◽  
Hematological Toxicity ◽  
Curative Gastrectomy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Abstract BackgroundTo evaluate the feasibility, safety, and efficacy of postoperative adjuvant chemotherapy with docetaxel/cisplatin/S-1 (DCS) following S-1 therapy in patients with stage III gastric cancer after curative gastrectomy.Methods Patients with stage III gastric cancer who underwent D2 gastrectomy were enrolled. Adjuvant chemotherapy was initiated within 8 weeks of gastrectomy. The first cycle of chemotherapy consisted of S-1 monotherapy (day 1–14), followed by a 7-day rest period. Cycles 2 and 3 consisted of the following: S-1 (day 1–14) administration, followed by a 14-day rest period, and an intravenous infusion of cisplatin and docetaxel on days 1 and 15. After 2 cycles, S-1 was administered for up to 1 year.Results Thirty patients were enrolled between 2013 and 2017. Febrile neutropenia of grade 3 or higher was the most common hematological toxicity with 4 patients (13.3%). Other hematological toxicities of grade 3 or higher were as follows: neutropenia in 3 (10.0%), leukopenia in 3 (10.0%), and anemia in 2 (6.7%). Most frequent non-hematological toxicity of grade 3 was anorexia (n=4, 13.3%) and general fatigue (n=3, 10.0%); no grade 4 non-hematological toxicities were observed. Twenty-five patients (83.3%) completed 2 cycles of DCS treatment and 18 (60.0%) completed subsequent S-1 treatment for 1 year. The relative dose intensity of docetaxel and cisplatin was 0.86 and that of S-1 was 0.88. Conclusion The DCS regimen can be acceptable as an adjuvant chemotherapy and offers an effective postoperative treatment option for stage III gastric cancer patients.Trial registration number: UMIN000012785 Date of registry: 08/01/2014

A phase II study of weekly paclitaxel and doxifluridine (an intermediate metabolite of capecitabine) combination chemotherapy for advanced/recurrent gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4593-4593
Author(s):  
I. Takeyoshi ◽  
F. Makita ◽  
Y. Tanahashi ◽  
S. Iwazaki ◽  
S. Nakamura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Single Agent ◽  
Dose Intensity ◽  
Intention To Treat ◽  
First Line Therapy ◽  
Line Therapy ◽  
Recurrent Gastric Cancer ◽  
Intermediate Metabolite

4593 Background: Paclitaxel and doxifluridine (5’-DFUR; an intermediate metabolite of capecitabine), which have distinct mechanisms of action and toxicity profiles, each have considerable single-agent activity in gastric cancer. A synergistic interaction between these two drugs was suggested from the taxane-induced upregulation of thymidine phosphorylase, which converts 5’-DFUR to 5-FU. Therefore, this study evaluated the antitumor activity and toxicities of paclitaxel and 5’-DFUR in combination in patients with advanced/recurrent gastric cancer (AGC) Methods: Patients with histologically confirmed AGC, which was unresectable or metastatic, PS 0–2, and over 20 years old were eligible for this study. The treatment included paclitaxel 80 mg/m2 i.v. on days 1, 8, and 15 every 4 weeks and doxifluridine 533 mg/m2 p.o. on days 1–5/week until there was disease progression or the appearance of unacceptable toxicity. Results: Between April 2003 and May 2006,104 patients were enrolled in this study. Their median age was 67.0 years (range: 36–82) and 87 patients were male. Forty-three patients had advanced gastric cancer and 61 had recurrent gastric cancer. After a median of 3 (range: 1- 21) cycles of chemotherapy, 104 patients were evaluated for toxicity and 93 patients were evaluated for response. In the intention-to-treat analysis, the overall response rate was 32.3% (95% C.I., 22.8–41.8%), including 2 CR, 28 PRs, 37 SDs, 16 PDs, and 10 NEs. The first-line therapy involved 48 patients (primary advanced or surgery alone) in whom the response rate was 41.7% (95% C.I., 27.7–55.6%). The second-line therapy involved 40 patients (72.5% TS-1 failure) in whom the response rate was 22.5% (95% C.I., 9.6–35.4%). The median overall survival was 287 days. The actual dose intensity was 81.7% (85/104) of the planned dose during the first two cycles for both drugs. Commonly observed grade 3/4 adverse events were leukopenia (13.5%), anorexia (3.8%), fatigue (3.8%), and diarrhea (2.9%).There was no neutropenic fever or treatment-related death. Conclusions: These data suggest that Paclitaxel and 5’-DFUR combination chemotherapy is a well tolerated convenient out-patient combination with very promising efficacy for AGC. No significant financial relationships to disclose.

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