• Title/Summary/Keyword: Prognostic significance

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A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.315-327
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    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

High versus Low Dose-Rate Intracavitary Irradiation for Adenocarcinoma of the Uterine Cervix (자궁경부 선암 환자에서 고선량률 강내치료와 저선량률 강내치료의 비교)

  • Kim Woo Chul;Kim Gwi Eon;Chung Eun Ji;Suh Chang Ok;Hong Soon Won;Cho Young Kap;Loh JK
    • Radiation Oncology Journal
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    • v.18 no.1
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    • pp.32-39
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    • 2000
  • Purpose :The incidence of adenocarcinoma of the uterine cervix is low. Traditionally, Low Dose Rate (LDR) brachytherapy has been used as a standard modality in the treatment for patients with carcinoma of the uterine cervix. The purpose of this report is to evaluate the effects of the High dose rate (HDR) brachytherapy in the patients with adenocarcinoma of the uterine cervix compared with the LDR. : From January 1971 to December 1992, 106 patients of adenocarcinoma of uterine cervix were treated with radiation therapy in the Department of Radiation Oncology, Yonsei University with curative intent. LDR brachytherapy was carried out on 35 patients and 71 patients were treated with HDR brachytherapy. In LDR Group, 8 patients were in stage I, 18 in stage II and 9 in stage III. External radiation therapy was delivered with 10 MV X-ray, daily 2 Gy fractionation, total dose 40$\~$46Gy (median 48 Gy). And LDR Radium intracavitary irradiation was peformed with Henschke applicator, 22$\~$59 Gy to point A (median 43 Gy). In HDR Group, there were 16 patients in stage 1, 38 in stage II and 17 in stage III. The total dose of external radiation was 40$\~$61 Gy(median 45 Gy), daily 1.8$\~$2.0 Gy. HDR Co-60 intracavitary irradiation was peformed with RALS (Remote Afterloading System), 30 $\~$ 57 Gy(median 39 Gy) to point A, 3 times a week, 3 Gy per fraction. Conclusion : The 5-year overall survival rate in LDR Group was 72.9$\%$, 61.9$\%$, 45.0$\%$ in stage I, II, III, respectively and corresponding figures for HDR were 87.1$\%$, 58.3$\%$, 41.2$\%$, respectively (p>0.05). There was no statistical difference in terms of the 5-year overall survival rate between HDR Group and LDR Group in adenocarcinoma of the uterine cervix. There was 11$\%$ of late complication rates in LDR Group and 27$\%$ in HDR Group. There were no prognostic factors compared HDR with LDR group. The incidence of the late complication rate in HDR Group stage II, III was higher than that in LDR Group(16.7$\%$ vs. 31.6$\%$ in stage II, 11.1$\%$ vs. 35.3$\%$ In stage III, p>0.05). Although the incidence of radiation induced late complication rate was higher in HDR Group stage II and III patients than that in the LDR Group, statistical significance was not detected and within acceptable level. Conclusion : There was no difference in terms of 5-year survival rate and failure pattern in the patients with adenocarcinoma of the uterine cervix treated with HDR and LDR brachytherapy. Even late complication rates were higher in the HDR group It was an acceptable range. This retrospective study suggests that HDR brachytherapy seems to replace the LDR brachytherapy in the adenocarcinoma of the uterine cervix. However, further studies will be required to refine the dose rate effects.

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