A multi-center, open-label, randomized phase III trial of first-line chemotherapy with capecitabine monotherapy versus capecitabine plus oxaliplatin in elderly patients with advanced gastric cancer

Hwang, In Gyu; Ji, Jun Ho; Kang, Jung Hun; Lee, Hyo Rak; Lee, Hui Young; Choun, Kyong; Park, Suk Won; Lee, Su Jin; Kim, Seung Tae; Lee, Jeeyun; Park, Se Hoon; Park, Joon Oh; Park, Young Suk; Lim, Ho Yeong; Kang, Won Ki

doi:10.1016/j.jgo.2017.01.002

Cited by 40 publications

(37 citation statements)

References 19 publications

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“…In one of these studies, there was no significant difference in OS between the S-1 and SP groups, even after propensity score matching [3]. Furthermore, in a small phase III trial from Korea, comparing capecitabine with capecitabine and oxaliplatin in 50 elderly (≥70 years) RPMGC patients, there was no significant difference in OS, with higher incidence of some toxicities in CC arm [23]. In the current study cohort of elderly patients (≥ 70 years), only 3.8% of the CC group were in PS 2, while 25% of the SC group were in PS 2 (p = 0.001).…”

Section: Discussionmentioning

confidence: 99%

Combination versus single-agent as palliative chemotherapy for gastric cancer

Choi

Kang

et al. 2020

BMC Cancer

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Background: Although combination chemotherapy (CC) is generally recommended in recurrent or primary metastatic gastric cancer (RPMGC), the results of randomized trials are conflicting. Methods: A retrospective review was conducted on 687 RPMGC patients who received palliative chemotherapy. We compared the overall survival (OS) between CC and single-agent chemotherapy (SC) among these patients, and we analyzed the clinicopathological characteristics affecting outcome including neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). Results: Although 521 patients (75.8%) underwent CC, SC was more frequently performed in elderly patients (57.6%) and ECOG performance status (PS) 2 or 3 (65.8%) patients (p < 0.0001, in each case). The median OS of patients who received CC was significantly longer than that of patients who received SC (11 vs. 8 months, p < 0.0001). No difference in OS between CC and SC was observed in elderly patients (p = 0.583), poor PS (p = 0.810), signet ring cell (p = 0.347), palliative surgical resection (p = 0.307), and high PLR (p = 0.120), with a significant interaction between age and type of regimen (p = 0.012). Moreover, there was no difference in OS between CC and SC after propensity score matching (p = 0.322). Multivariate analysis revealed that palliative resection and ≥ second-line chemotherapy were independently associated with favorable OS (p < 0.0001, in each case), whereas poor PS (p = 0.004), signet ring cell (p < 0.0001), peritoneal metastasis (p = 0.04), high NLR (p = 0.001), and high PLR (p = 0.033) were independent prognostic factors of poor OS. Conclusions: Although CC is the standard of care in RPMGC, SC can be considered a reasonable option in certain subgroups, such as elderly patients.

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Section: Discussionmentioning

confidence: 99%

Combination versus single-agent as palliative chemotherapy for gastric cancer

Choi

Kang

et al. 2020

BMC Cancer

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“…Thirdly, treatment adherence has not been assessed, which is a key consideration in older AGC patients receiving oral treatments (29).Fourthly, given the registry eligibility criteria, single-agent chemotherapy has not been contemplated, although in unselected patients with AGC, combination treatment is deemed more efficacious than single-agent chemotherapy in terms of OS (30);in the case of older patients, however, the literature is scarce. In this sense, a randomized trial recently carried out specifically in older individuals concluded that OS with the combination of oxaliplatin and capecitabine was superior to capecitabine in single-agent chemotherapy (31). However, other series suggest that single-agent chemotherapy is the most appropriate option for some cases (32).Finally, the effect of second-lines of chemotherapy has not been considered (33).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of chemotherapy in older versus non-older patients with advanced gastric cancer: A real-world data, non-inferiority analysis

Visa

Jiménez‐Fonseca

Martínez

et al. 2018

Journal of Geriatric Oncology

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“… 25 Peripheral neuropathy was graded according to the oxaliplatin-specific scale: grade 1, paresthesias or dysesthesias of short duration with complete recovery before the next cycle; grade 2, paresthesias persisting for two cycles without functional impairment; and grade 3, permanent paresthesias interfering with function. 14 …”

Section: Methodsmentioning

confidence: 99%

“…Oxaliplatin has been shown to be better tolerated than cisplatin, especially in older patients, 14 , 15 and has proven efficacy in combination with 5-FU. 16 , 17 Therefore, the combination chemotherapy of 5-FU with oxaliplatin has been studied in numerous Phase II studies, using different doses and schedules, and the outcomes were satisfactory.…”

Section: Introductionmentioning

confidence: 99%

Comparison of FOLFOX and DOF regimens as first-line treatment in East Asian patients with advanced gastric cancer

Liu¹,

Hu²,

Wang³

et al. 2018

OTT

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BackgroundOur study retrospectively assesses the safety and efficacy of the FOLFOX (oxaliplatin, fluorouracil, and leucovorin) versus DOF (docetaxel, oxaliplatin, and fluorouracil) regimens in untreated locally advanced gastric cancer (AGC).Patients and methodsA total of 108 patients underwent DOF (N=58) and FOLFOX (N=50) regimens. The end points were overall response rate (ORR), survival, and toxicity. Kaplan–Meier curve was used to estimate overall survival (OS) and progression-free survival (PFS) and Cox regression for multivariate analysis.ResultsThe ORRs were 50% for DOF and 30% for FOLFOX groups (P<0.05), and disease control rates were 91.4% and 72%, respectively. The median PFS and OS in DOF group were significantly better than FOLFOX group (8.2 versus 6.4 months, P<0.05; 16.3 versus 11.2 months, P<0.001). Both groups showed acceptable toxicity; all grades and grade 3–4 toxicity had no significant differences (P=0.071; P=0.247). However, the incidence of grade 3–4 peripheral neuropathy was significantly higher in DOF group (10.3% versus 2%, P<0.05). In the subgroup analysis for elderly AGC patients (≥65 years), administration of DOF also resulted in a superior PFS (8.5 versus 5.9 months; P=0.038) and OS (15.3 versus 9.8 months; P=0.004) compared with FOLFOX. However, DOF regimen was associated with more neutropenia (67% versus 30%; P<0.05), thrombocytopenia (61% versus 52%; P<0.05), and peripheral neuropathy (49% versus 22%; P<0.05).ConclusionDOF regimen was more effective than FOLFOX for AGC, both in younger and older patients. The adverse effects of the two regimens were manageable. The combination of docetaxel/oxaliplatin/fluorouracil was active and well tolerated in AGC patients and deserves further evaluation. However, for elderly patients with AGC, the DOF regimen was associated with worse toxicities; therefore, the FOLFOX regimen might be a more suitable option.

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A multi-center, open-label, randomized phase III trial of first-line chemotherapy with capecitabine monotherapy versus capecitabine plus oxaliplatin in elderly patients with advanced gastric cancer

Cited by 40 publications

References 19 publications

Combination versus single-agent as palliative chemotherapy for gastric cancer

Combination versus single-agent as palliative chemotherapy for gastric cancer

Efficacy and safety of chemotherapy in older versus non-older patients with advanced gastric cancer: A real-world data, non-inferiority analysis

Comparison of FOLFOX and DOF regimens as first-line treatment in East Asian patients with advanced gastric cancer

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