A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

Lee, J-L.; Kang, Yubin; Kang, Hye Jin; Kh, Lee; Zang, Dae Young; Ryoo, B-Y.; Kim, J G; Park, S R; Kang, Wonseok; Shin, DB; Ryu, M.-H.; Chang, Heung-Moon; Tw, Kim; Baek, Jin Ho; Min, Young Joo

doi:10.1038/sj.bjc.6604536

Cited by 125 publications

(109 citation statements)

References 37 publications

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“…Lee et al [24] and Koizumi et al [25] reported the following incidences of grade 3/4 toxicities: decrease in serum hemoglobin, 9%-14.3%; anorexia, 9.5%-12%; and nausea, 4.8%-6%. These data are similar to those in the middle-aged group in the present study (decrease in serum hemoglobin, 18%; anorexia, 6%; nausea, 5%).…”

Section: Discussionmentioning

confidence: 99%

“…Lee et al [24] conducted a randomized phase II study comparing capecitabine and S-1 in patients older than 65 years, and showed satisfactory effi cacy of S-1 (RR, 29%; median time to progression, 4.2 months; median OS, 8.1 months). In Japan, Koizumi et al [25] conducted a phase II study of S-1 in patients older than 75 years and demonstrated a RR of 21%, median PFS of 3.9 months, and median OS of 15.7 months.…”

Section: Discussionmentioning

confidence: 99%

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Safety and efficacy of S-1 monotherapy in elderly patients with advanced gastric cancer

et al. 2010

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cancer is the most frequently encountered malignancy and the second leading cause of cancer-related death [3]. The prognosis of unresectable or recurrent tumors is very poor: the median survival time is about 4 months with best supportive care [4][5][6]. Although several randomized trials of treatments for advanced gastric cancer were conducted during the 1990s, with anthracyclines, mitomycin C, 5-fl uorouracil (5-FU), methotrexate, and cisplatin [7][8][9][10][11][12][13][14][15], no standard treatment for advanced gastric cancer was established.S-1 is an oral fl uoropyrimidine, consisting of tegafur (a prodrug of fl uorouracil), 5-chloro-2, 4-dihydropyrimidine (CDHP), and potassium oxonate. CDHP is an inhibitor of dihydropyrimidine dehydrogenase (DPD), which is the rate-limiting enzyme for the degradation of fl uorouracil [16]. Three randomized controlled trials of S-1 monotherapy have been reported from Japan. One was the Japan Clinical Oncology Group (JCOG) 9912 trial, which showed the noninferiority of S-1 to continuous infusion of 5-FU, adopted as the reference arm for patients with unresectable or recurrent gastric cancer, based on the result of the JCOG9205 trial [15,17]. The second trial was the S-1 plus cisplatin versus S-1 in RCT in the treatment for stomach cancer (SPIRITS) trial, conducted in 2007, which showed the superiority of S-1 plus cisplatin to S-1 alone in patients with advanced gastric cancer [18]. The third trial was the randomized phase III study of irinotecan plus S-1 (IRIS) versus S-1 alone as fi rst-line treatment for advanced gastric cancer (GC0301/TOP-002), which did not demonstrate the superiority of S-1 plus irinotecan (CPT-11) to S-1 alone [19]. From the results of these three phase III trials, S-1 plus cisplatin came to be recognized as the standard of care for patients with advanced gastric cancer in Japan, while S-1 monotherapy was a community standard until 2007.In recent years, the percentage of elderly people in the general population in Japan has increased remarkably, to more than 20%, owing to the prolonged lifespan of the Abstract Background. Although S-1 is effective against advanced gastric cancer (AGC), its effi cacy in elderly patients has not yet been investigated suffi ciently. We assessed the effi cacy and safety of S-1 monotherapy in elderly patients with AGC. Methods. We conducted a retrospective review of the data of 153 patients with unresectable/recurrent gastric adenocarcinoma who received S-1 monotherapy as fi rst-line chemotherapy at our institution. S-1 was administered orally twice daily at the dose of 40 mg/m 2 , on days 1-28, every 6 weeks. We categorized the patients into three groups, the young (≤65 years old), the middle-aged (66-75 years old), and the elderly (≥76 years old); and the drug toxicity, objective responses, progression-free survivals, and overall survivals were compared among the three groups. Results. The incidence of leukopenia of grade 3 or greater in the three groups was 7%, 5%, and 13%, and that of anemia was 9%, 18%, and 27%, respec...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of S-1 monotherapy in elderly patients with advanced gastric cancer

et al. 2010

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“…Although the most commonly used first-line chemotherapy regimen was fluoropyrimidine with/without platinum (60-75 %) [15][16][17][18][19][20][21][22][23], some feasible patients, who had good performance or low tumor burden such as isolated para-aortic lymph node metastasis, were treated with a triplet regimen including taxane, fluoropyrimidine and platinum [26][27][28]. Those were about 8 % of all patients (290 patients) over all the periods, and their survival outcome of 7.8 months in PFS (95 % CI 7.0-8.6 months) and 14.0 months in OS (95 % CI 12.6-15.4 months) was not significantly different among the three periods (p = 0.485, p = 0.512, respectively).…”

Section: Discussionmentioning

confidence: 99%

“…The most commonly used firstline cytotoxic chemotherapy agent was fluoropyrimidine with/without platinum: 579 (65.8 %) in period 1, 1083 (68.8 %) in period 2 and 1153 (80.3 %) in period 3. The most commonly used first-line chemotherapy regimen was fluoropyrimidine with/without platinum (60-75 %) [15][16][17][18][19][20][21][22][23], and taxane-based chemotherapy was most commonly used as second line (50 %) [24,25]. A triplet regimen including taxane, fluoropyrimidine and platinum was administered to *8 % of patients over all periods [26][27][28].…”

Section: Betweenmentioning

confidence: 99%

Improving trends in survival of patients who receive chemotherapy for metastatic or recurrent gastric cancer: 12 years of experience at a single institution

et al. 2014

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Background The aim of this retrospective study was to evaluate the changes in clinical features and treatment outcomes of the patients with metastatic or recurrent gastric cancer (MRGC) treated in the past 12 years. Results There were 880 patients (23 %) in period 1, 1573 (40 %) in period 2 and 1435 (37 %) in period 3. The most commonly used first-line chemotherapy regimen was fluoropyrimidine with/without platinum (72 %) for all periods. The use of second-and third-line chemotherapy was slightly but significantly more common in the two recent periods: 46 and 19 % in period 1, 54 and 26 % in period 2, and 53 and 27 % in period 3, respectively. Overall, 3494 patients (89.9 %) died with a median overall survival (OS) of 10.6 months (95 % CI 10.2-11.0). The OS was statistically significantly improved over the study period: 9.6 months (95 % CI 9.0-10.2) in period 1, 10.3 months (95 % CI 9.8-10.9) in period 2 and 11.7 months (95 % CI 11.0-12.4) in period 3 (p for trend \0.001). Multivariate analysis including eight prognostic factors (performance, gastrectomy, peritoneal/bone/lung metastasis, abnormal alkaline phosphatase/albumin/total bilirubin) showed that the more recent treatment period was an independent favorable prognostic factor for OS (p \ 0.001). Conclusion The OS of patients who receive chemotherapy for MRGC has been shown to improve over time.

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“…Given the large numbers of trials and the many different comparisons in the trials retrieved, the gi dsg made an a posteriori decision to focus on the individual contributions of fluoropyrimidines 20,24,25,28,[32][33][34][35][36][37][38][39][40] , platinum agents 9,23,26,30,36,[41][42][43][44][45] , anthracyclines 34,46 -50,79 , taxanes 22,51,52 , and irinotecan 9,53 . The dsg also decided to determine whether the available evidence supports the regimens that are currently in common use in Ontario 21,24,25,36,48,[55][56][57][58] and to determine the contribution of targeted therapies 59,80 .…”

Section: Resultsmentioning

confidence: 99%

Systemic Therapy for Advanced Gastric Cancer: A Clinical Practice Guideline

2011

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• Within a combination chemotherapy regimen, oral capecitabine is preferred over intravenous 5-fluorouracil (5fu)-that is, epirubicin-cisplatincapecitabine is preferred over the prior standard regimen, epirubicin-cisplatin-5fu (ecf).• Epirubicin-oxaliplatin-capecitabine (eox) is a reasonable alternative to ecf. The choice between ecf and eox should be based on patient preference.• Trastuzumab in combination with cisplatin and a fluoropyrimidine (5fu or oral capecitabine) is recommended for advanced gastric cancer positive for the human epidermal growth factor receptor 2 (her2/neu). KEY WORDSAdvanced gastric cancer, systemic therapy, practice guideline QUESTIONWhat is the optimal chemotherapy regimen in advanced gastric cancer? Outcomes of interest were overall survival (os), objective response rate (complete plus partial responses), time to disease progression, adverse effects, and quality of life. INTRODUCTIONGastric cancer is a virulent disease that is the second leading cause of cancer mortality worldwide 1 . There is significant geographic variation in the incidence of gastric cancer, with incidence and mortality being particularly high in Japan, China, Korea, Chile, and Costa Rica 2 . Even though the incidence rate for gastric cancer in Ontario is one of the lowest worldwide 3 , overall prognosis is bleak, with 5-year survival rates of approximately 23% in Canada 4 and 23%-25% in the United States for all stages combined 5 .Despite the considerable body of research available on chemotherapy for advanced gastric cancer, ABSTRACT QuestionWhat is the optimal chemotherapy regimen in advanced gastric cancer? PerspectivesGastric cancer is the second leading cause of cancer mortality worldwide. Despite low incidence rates for gastric cancer in Ontario, the overall prognosis is bleak, with 5-year survival rates of approximately 23% in Canada. Even with the considerable body of research available on chemotherapy for advanced gastric cancer, uncertainty remains. There is no recognized standard treatment, and there appears to be geographic variation in practice. OutcomesOutcomes of interest were overall survival, objective response rate (complete plus partial responses), time to disease progression, adverse effects, and quality of life. MethodologyAfter a systematic review, a practice guideline containing clinical recommendations relevant to patients in Ontario was drafted. The practice guideline was reviewed and approved by the Gastrointestinal Disease Site Group (gi dsg) and the Report Approval Panel of the Program in Evidence-Based Care. External review by Ontario practitioners was obtained through a survey, the results of which were incorporated into the practice guideline. Practice GuidelineThe gi dsg makes the following recommendations:• To improve survival, a platinum agent should be included in any combination chemotherapy regimen.

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A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

Cited by 125 publications

References 37 publications

Safety and efficacy of S-1 monotherapy in elderly patients with advanced gastric cancer

Safety and efficacy of S-1 monotherapy in elderly patients with advanced gastric cancer

Improving trends in survival of patients who receive chemotherapy for metastatic or recurrent gastric cancer: 12 years of experience at a single institution

Systemic Therapy for Advanced Gastric Cancer: A Clinical Practice Guideline

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