Randomized phase II trial of neoadjuvant vs. adjuvant docetaxel plus cisplatin in patients with locally advanced gastric carcinoma: An interim analysis

Chun, June Young; Park, S.; Kim, H.; Kim, Y.; Ryu, Keun Won; Lee, J.; Kim, C.; Bae, Jaeman

doi:10.1200/jco.2006.24.18_suppl.4030

Cited by 4 publications

(4 citation statements)

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“…12,13 Neoadjuvant chemotherapy is not generally recommended for Korean patients with gastric cancer. 14,15 One of the major revisions in the seventh edition of the AJCC TNM classification is alteration of the pT2 classification. Although the sixth edition pT2 classification was subclassified as pT2a and pT2b, each subgroup is not an individual determinant of final TNM staging.…”

Section: Discussionsupporting

confidence: 48%

Validation of the seventh edition of the American Joint Committee on Cancer TNM staging system for gastric cancer

Jung

Lee

Song

et al. 2011

Cancer

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BACKGROUND:The seventh edition of the American Joint Committee on Cancer (AJCC) TNM classification for gastric cancer was published in 2010 and included major revisions. The aim of the current study was to evaluate the validity of the seventh edition TNM classification for gastric cancer based on an Asian population. METHODS: A total of 2916 gastric cancer patients who underwent R0 surgical resection from 1989 through 2008 in a single institute were included, and were analyzed according to the seventh edition of the TNM classification for validation. RESULTS: When adjusted using the seventh edition of the TNM classification, upstaging was observed in 771 patients (26.4%) and downstaging was observed in 178 patients (6.1%) compared with the sixth edition of the TNM classification. The relative risk (RR) of seventh edition pT classification was found to be increased with regular intensity compared with the sixth edition pT classification. The RR of seventh edition pN classification was found to be increased with irregular intensity compared with the sixth edition pN classification. In survival analysis, there were significant differences noted for each stage of disease, but only a marginal difference was demonstrated between stage IA and stage IB (P ¼ .049). In the hybrid TNM classification, which combines the seventh edition pT classification and the sixth edition pN classification, both pT and pN classifications demonstrated a more ideal distribution of the RR, and 5-year survival rates also showed a significant difference for each stage (P <.01). CONCLUSIONS: The seventh edition of the TNM classification was considered valid based on the results of the current study. However, the hybrid TNM classification, comprised of a combination of the seventh edition pT classification and sixth edition pN classification, should be considered for the next edition.

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Section: Discussionsupporting

confidence: 48%

Validation of the seventh edition of the American Joint Committee on Cancer TNM staging system for gastric cancer

Jung

Lee

Song

et al. 2011

Cancer

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“…A randomized phase II study has been conducted to evaluate the efficacy of neoadjuvant versus adjuvant cisplatin/docetaxel in patients with gastric cancer and, as expected, there was a significantly lower incidence of grade 3 or 4 toxicities in the neoadjuvant arm, but survival data are not yet available to indicate which strategy might be associated with the better final outcome. 87 Similarly, a recently published randomized phase II study assessed safety and efficacy of DCF administered before or after surgery. The study confirmed that neo-adjuvant DCF is effective (with 85% R0 resections) and safe (with no surgical mortality and 28.5% morbidity rate).…”

Section: Docetaxel In Neoadjuvant/adjuvant Treatment Settingsmentioning

confidence: 99%

Section: Docetaxel In Neoadjuvant/adjuvant Treatment Settingsmentioning

confidence: 99%

A Review of Docetaxel: Its Use in the Treatment of Gastric Cancer

Inno

Basso

Cassano

et al. 2010

Clinical Medicine Insights: Therapeutics

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Docetaxel, a member of the taxane family, promotes cell death by binding β-tubulin and has demonstrated activity against several human malignancies, both as a single agent and in combination therapy. It has been approved in Europe and the US as front-line treatment for advanced gastric cancer in combination with cisplatin and fluorouracil (DCF regimen). This approval was based on the results of a pivotal study (V325) which demonstrated that the addition of docetaxel to the reference regimen of cisplatin and fluorouracil improves overall survival and progression-free survival with a better quality of life despite increased toxicity (mainly haematological). Modifications of DCF regimen have been successfully investigated as a means of making the treatment more tolerable and suitable also for elderly patients or patients with poor performance status. Emerging data from several phase II studies suggest that other docetaxelbased combination regimens with anthracyclines or irinotecan have interesting activity with acceptable toxicity profiles, but the true efficacy of these regimens needs to be assessed in large randomized phase III studies. Thus, the best docetaxel-containing regimen has yet to be identified. Docetaxel also represents a good candidate for combination with novel molecular target agents. In light of the high response rates observed in phase II-III studies, a docetaxel-based chemotherapy regimen might also be considered a treatment option as perioperative or adjuvant therapy in potentially curable gastric cancer and further studies with or without biological agents are eagerly awaited in this setting.

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“…To date, only a few results of phase II trials assessing the outcomes of neoadjuvant chemotherapy have been conducted in East Asia countries [ 11 12 13 14 15 ]. In our previous phase II study of perioperative chemotherapy, S-1 combined with weekly docetaxel for patients with locally advanced gastric cancer (LAGC) showed good long-term results with manageable toxicity [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Survival Benefit of Perioperative Chemotherapy in Patients with Locally Advanced Gastric Cancer: a Propensity Score Matched Analysis

Eom

Kim

et al. 2018

J Gastric Cancer

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PurposeIt has been reported that the survival of patients with locally advanced gastric cancer (LAGC) is better in East Asia countries than in developed western countries; however, the prognosis of LAGC remains poor. This study aimed to evaluate the effects of perioperative chemotherapy on the long-term survival of East Asia patients with LAGC.Materials and MethodsFrom October 2006 through August 2008, 43 patients with LAGC received perioperative S-1 combined with weekly docetaxel in a phase II study (neoadjuvant group). These patients were matched using propensity scores to patients who underwent surgery without neoadjuvant chemotherapy during the same period (surgery group). The surgical outcomes and long-term survivals were compared between the 2 groups.ResultsAfter matching, 43 and 86 patients were included in the neoadjuvant and surgery groups, respectively, and there was no significant difference in their baseline characteristics. Although the operating time was longer in the neoadjuvant group, there was no significant difference in postoperative complications between the 2 groups. The neoadjuvant group had a significantly higher 5-year overall survival (OS) rate (73.3% vs. 51.1%, P=0.005) and a trend towards higher 5-year progression-free survival (PFS) (62.8% vs. 49.9%, P=0.145). In the multivariate analysis, perioperative chemotherapy was an independent factor for OS, with a hazard ratio of 0.4 (P=0.005) and a marginal effect on the PFS (P=0.054).ConclusionsPerioperative chemotherapy was associated with better long-term survival without increasing postoperative complications in the setting of D2 surgery for patients with LAGC, suggesting that perioperative chemotherapy can be a therapeutic option in East Asia countries.

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Randomized phase II trial of neoadjuvant vs. adjuvant docetaxel plus cisplatin in patients with locally advanced gastric carcinoma: An interim analysis

Cited by 4 publications

References 0 publications

Validation of the seventh edition of the American Joint Committee on Cancer TNM staging system for gastric cancer

Validation of the seventh edition of the American Joint Committee on Cancer TNM staging system for gastric cancer

A Review of Docetaxel: Its Use in the Treatment of Gastric Cancer

Survival Benefit of Perioperative Chemotherapy in Patients with Locally Advanced Gastric Cancer: a Propensity Score Matched Analysis

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