Five-Year Outcomes of a Randomized Phase III Trial Comparing Adjuvant Chemotherapy With S-1 Versus Surgery Alone in Stage II or III Gastric Cancer

2011 ◽  
Vol 29 (33) ◽  
pp. 4387-4393 ◽  
Author(s):  
Mitsuru Sasako ◽  
Shinichi Sakuramoto ◽  
Hitoshi Katai ◽  
Taira Kinoshita ◽  
Hiroshi Furukawa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Disease Stage ◽  
Relapse Free Survival ◽  
Free Survival ◽  
End Point

Purpose The first planned interim analysis (median follow-up, 3 years) of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer confirmed that the oral fluoropyrimidine derivative S-1 significantly improved overall survival, the primary end point. The results were therefore opened at the recommendation of an independent data and safety monitoring committee. We report 5-year follow-up data on patients enrolled onto the ACTS-GC study. Patients and Methods Patients with histologically confirmed stage II or III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive S-1 after surgery or surgery only. S-1 (80 to 120 mg per day) was given for 4 weeks, followed by 2 weeks of rest. This 6-week cycle was repeated for 1 year. The primary end point was overall survival, and the secondary end points were relapse-free survival and safety. Results The overall survival rate at 5 years was 71.7% in the S-1 group and 61.1% in the surgery-only group (hazard ratio [HR], 0.669; 95% CI, 0.540 to 0.828). The relapse-free survival rate at 5 years was 65.4% in the S-1 group and 53.1% in the surgery-only group (HR, 0.653; 95% CI, 0.537 to 0.793). Subgroup analyses according to principal demographic factors such as sex, age, disease stage, and histologic type showed no interaction between treatment and any characteristic. Conclusion On the basis of 5-year follow-up data, postoperative adjuvant therapy with S-1 was confirmed to improve overall survival and relapse-free survival in patients with stage II or III gastric cancer who had undergone D2 gastrectomy.

Randomized Trial of Adjuvant Chemotherapy With Mitomycin, Fluorouracil, and Cytosine Arabinoside Followed by Oral Fluorouracil in Serosa-Negative Gastric Cancer: Japan Clinical Oncology Group 9206–1

2003 ◽  
Vol 21 (12) ◽  
pp. 2282-2287 ◽  
Author(s):  
Atsushi Nashimoto ◽  
Toshifusa Nakajima ◽  
Hiroshi Furukawa ◽  
Masatsugu Kitamura ◽  
Taira Kinoshita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Survival Benefit ◽  
Curative Resection ◽  
Cancer Recurrence ◽  
Phase Iii ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Significant Difference

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated. Patients and Methods: From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, fluorouracil (FU) 166.7 mg/m2, and cytarabine 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points. Results: Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P = .14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P = .13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence. Conclusion: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.

Randomized Clinical Trial of Adjuvant Mitomycin Plus Tegafur in Patients With Resected Stage III Gastric Cancer

1999 ◽  
Vol 17 (12) ◽  
pp. 3810-3815 ◽  
Author(s):  
Lluís Cirera ◽  
Anna Balil ◽  
Eduard Batiste-Alentorn ◽  
Ignasi Tusquets ◽  
Teresa Cardona ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Free Survival ◽  
Resected Stage ◽  
Disease Free

PURPOSE: The efficacy of adjuvant chemotherapy in gastric cancer is controversial. We conducted a phase III, randomized, multicentric clinical trial with the goal of assessing the efficacy of the combination of mitomycin plus tegafur in prolonging the disease-free survival and overall survival of patients with resected stage III gastric cancer. PATIENTS AND METHODS: Patients with resected stage III gastric adenocarcinoma were randomly assigned, using sealed envelopes, to receive either chemotherapy or no further treatment. Chemotherapy was started within 28 days after surgery according to the following schedule: mitomycin 20 mg/m2 intravenously (bolus) at day 1 of chemotherapy; 30 days later, oral tegafur at 400 mg bid daily for 3 months. Disease-free survival and overall survival were estimated using the Kaplan-Meier analysis and the Cox proportional hazards model. RESULTS: Between January 1988 and September 1994, 148 patients from 10 hospitals in Catalonia, Spain, were included in the study. The median follow-up period was 37 months. The tolerability of the treatment was excellent. The overall survival and disease-free survival were higher in the group of patients treated with chemotherapy (P = .04 for survival and P = .01 for disease-free survival in the log-rank test). The overall 5-year survival rate and the 5-year disease-free survival rate were, respectively, 56% and 51% in the treatment group and 36% and 31% in the control group. CONCLUSION: Our positive results are consistent with the results of recent studies; which conclude that there is a potential benefit from adjuvant chemotherapy in resected gastric cancer.

scholarly journals Neoadjuvant Chemotherapy with Fluorouracil plus Leucovorin, Oxaliplatin, and Docetaxel (FLOT) for Gastric Cancer Patients in China

2020 ◽  
Author(s):  
Birendra Kumar Sah ◽  
Xu Wei ◽  
Zhang Benyan ◽  
Zhang Huan ◽  
Yuan Fei ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Tumor Regression ◽  
Chinese Patients ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Grade 3 ◽  
Gastric Cancer Patients

AbstractPurposeNeoadjuvant fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) has shown significant benefits for gastric cancer patients. However, it has not been well accepted in Asian countries, so we conducted a prospective study on the safety and feasibility of this regimen in Chinese patients.MethodsPatients with adenocarcinoma of the stomach or esophagogastric junction received 4 cycles of neoadjuvant chemotherapy (NAC) and 4 cycles of adjuvant chemotherapy (AC) with the FLOT regimen. The completion status of chemotherapy, adverse events, postoperative morbidities and pathological tumor regression were analyzed. The two-year overall survival (OS) and relapse-free survival are presented.ResultsAltogether, 10 patients were enrolled, and all patients completed 4 cycles of neoadjuvant chemotherapy. There were no severe hematological adverse events (grade 3 or above), except for a case of grade 3 anemia. All 10 patients underwent radical gastrectomy. Nine patients had R0 resection, and 3 patients had complete or subtotal pathological tumor regression. Nine patients completed 4 cycles of adjuvant chemotherapy, but only one patient completed the full dose of adjuvant chemotherapy. The dose of adjuvant chemotherapy was reduced by 25% or less in the other patients. The median follow-up time was 23.13 months, 8 patients achieved the overall survival endpoint, and 7 patients had relapse-free survival for this period. Two patients died of disease progression.ConclusionsOur study demonstrates that neoadjuvant chemotherapy with FLOT regimen is safe and effective for Chinese patients. Dose adjustment is necessary for adjuvant chemotherapy. The pathological regression and survival rates need reevaluation in a larger cohort.

Randomized controlled phase II study of alternate-day S-1 as adjuvant chemotherapy for gastric cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 114-114
Author(s):  
Seiichi Nakamura ◽  
Shigeru Tatebe ◽  
Tetsu Shimizu ◽  
Nariyuki Yamane ◽  
Hideaki Nishidoi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Dose Intensity ◽  
Treatment Completion ◽  
Completion Rate ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Group A ◽  
Group B

114 Background: Based on the results of ACTS-GC, oral administration of S-1 for 1 year is considered standard postoperative adjuvant chemotherapy for gastric cancer in Japan. However, the 1-year treatment completion rate was only 65.8%, and completion of the treatment is a problem to be solved. On the other hand, we experienced in clinical practice that the alternate-day administration of S-1 reduced adverse effects and was tolerable for advanced gastric cancer patients unwilling to continue the standard daily administration. We therefore conducted a multi-center cooperative prospective study to compare daily with alternate-day administration of S-1 as postoperative adjuvant therapy for gastric cancer. Methods: Patients with Stage II or III gastric cancer who underwent curative surgery were randomly assigned to receive standard daily administration (group A: S-1 80-120 mg/day according to BSA, days 1 to 28, every 6weeks, for 1 year) or alternate-day administration of S-1 (group B: S-1 80-120 mg/day according to BSA, every other day, for 15 months). The primary endpoints were treatment completion rate and relative dose intensity. Secondary endpoints were safety, overall survival, and relapse-free survival. Results: A total of 73 patients were enrolled. As of August 30, 2011 analysis of the compliance data of 62 cases had been completed. The results showed a treatment completion rate of 74.2% in group A and 93.5% in group B and relative dose intensity of 72.1% in group A and 85.6% in group B, and compliance tended to be better in group B. Assessment of survival time showed a median follow-up time of 545 days, a 1-year survival rate of 93.8% in group A and 96.9% in group B and 1-year relapse-free survival rate of 79.5% in group A and 90.7% in group B. Digestive system adverse events were less frequent in group B than in group A. Conclusions: We will report the data from the final analysis at this meeting. The current data show improved compliance and mitigation of adverse effects with alternate-day administration of S-1, and it appears to be a more sustainable option for adjuvant chemotherapy for Stage II and III gastric cancer.

scholarly journals Feasibility and Safety of Perioperative Chemotherapy With Fluorouracil Plus Leucovorin, Oxaliplatin, and Docetaxel for Locally Advanced Gastric Cancer Patients in China

2021 ◽  
Vol 10 ◽  
Author(s):  
Birendra Kumar Sah ◽  
Wei Xu ◽  
Benyan Zhang ◽  
Huan Zhang ◽  
Fei Yuan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Tumor Regression ◽  
Chinese Patients ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Grade 3 ◽  
Gastric Cancer Patients

BackgroundNeoadjuvant fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) has shown significant benefits for gastric cancer patients. However, it has not been well accepted in Asian countries. We conducted a prospective study on the safety and feasibility of the FLOT regimen in Chinese patients.MethodsPatients with adenocarcinoma of the stomach or esophagogastric junction received four cycles of neoadjuvant chemotherapy (NAC) and four cycles of adjuvant chemotherapy (AC) with the FLOT regimen. The completion status of chemotherapy, adverse events, postoperative morbidities, and pathological tumor regression were analyzed. The 2-year overall survival (OS) and relapse-free survival are presented.ResultsAltogether, 10 patients were enrolled, and all patients completed four cycles of neoadjuvant chemotherapy. There were no severe hematological adverse events (grade 3 or above), except for a case of grade 3 anemia. All 10 patients underwent radical gastrectomy. Nine patients had R0 resection, and three patients had complete or subtotal pathological tumor regression. Nine patients completed four cycles of adjuvant chemotherapy, but only one patient completed the full dose of adjuvant chemotherapy. The dose of adjuvant chemotherapy was reduced by 25% or less in the other patients. The median follow-up time was 23.13 months, eight patients achieved the overall survival endpoint, and seven patients had relapse-free survival for this period. Two patients died of disease progression.ConclusionsOur study demonstrates that the neoadjuvant FLOT regimen is safe and effective for Chinese patients. Dose adjustment is necessary for adjuvant chemotherapy. The pathological regression and survival rates need reevaluation in a larger cohort. The trial is registered with ClinicalTrials.gov (number NCT03646591).

Hodgkin's Disease Stage I and II with Exclusive Subdiaphragmatic Presentation. The Experience of the Departments of Radiation Oncology and Hematology, University “La Sapienza” of Rome

1996 ◽  
Vol 82 (1) ◽  
pp. 48-52 ◽  
Author(s):  
Riccardo Maurizi Enrici ◽  
Mattia Falchetto Osti ◽  
Anna Paola Anselmo ◽  
Enzo Banelli ◽  
Claudio Cartoni ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Oncology ◽  
Hodgkin's Disease ◽  
Hodgkin’S Disease ◽  
Stage I ◽  
Stage Ii ◽  
Disease Stage ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Systemic Symptoms

During the period 1978 to 1994, 1054 patients with Hodgkin's disease were evaluated and treated at the Departments of Radiation Oncology and Hematology, University “La Sapienza”, Rome. A total of 549 patients presented with clinical or pathological stage I and II; 37 of these had Hodgkin's disease below the diaphragm (BDHD), and 512 above the diaphragm (ADHD). A comparison of patients with BDHD versus those with ADHD showed that the first group had a higher male to female ratio. A comparison of cases with stage II BDHD versus those with stage II ADHD showed that patients with BDHD were older (48 years vs 28 years), had different histologic features and a higher incidence of systemic symptoms (67% vs 33%). Stage II BDHD patients had a worse prognosis; in fact, there were significant differences in the overall survival and relapse-free-survival rates for cases with stage II BDHD versus those with stage II ADHD (overall survival, 46% vs 80%, P<0.001; relapse-free survival, 44% vs 69%, P<0.005). Stage was found to be the most important prognostic factor for BDHD cases without systemic symptoms treated with radiation therapy alone. The type of infradiaphragmatic presentation (intra-abdominal vs peripheral disease) did not influence outcome, probably due to the more aggressive therapy received by the intra-adbominal group. Treatment recommendations for BDHD cases should be tailored to the stage and the presence or absence of intra-abdominal localization. For patients with stage IA extended fields, irradiation (inverted Y) is sufficent. However, combined modality therapy should be the treatment of choice for stage II cases, particularly in the presence of intra-abdominal disease. Patients with systemic symptoms also require combined modalities.

scholarly journals Retrospective Cohort Study of Intraoperative Administration of Sustained-Release 5-Fluorouracil Implants in Advanced Gastric Cancer Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Jie Ge ◽  
Ting Liu ◽  
Tianxiang Lei ◽  
Xuan Li ◽  
Kun Song ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Cancer Patients ◽  
Progression Free Survival ◽  
Postoperative Chemotherapy ◽  
Control Group ◽  
Free Survival ◽  
Gastric Cancer Patients

Background: 5-fluorouracil (5-FU) is basically used in the field of postoperative chemotherapy of gastric cancer (GC), the goal of this study was to evaluate improvement of long-term survival rate among GC patients after the 5-FU implants treatment.Methods: The study included 145 patients with gastric cancer who received postoperative chemotherapy with 5-FU implants and had complete follow-up information. According to the sex, age and clinical stage of 5-FU implants group, 74 patients were matched as the control group at the same time. In the study, we compared the 5-year overall survival rate with progression-free survival rate in the two groups, and the drug safety for both groups during the treatment was also compared.Results: The median follow-up time was 85 months (range 60–116 months). 31 patients (21.38%) died of tumor recurrence in 5-FU implants group and 21 (28.38%) in control group. In the control group, metastatic lesions were found in the small intestine, left adrenal gland and peritoneum in three patients. The 5-year progression-free survival (PFS) rate was 79.71% in 5-FU group and 67.12% in control (p = 0.0045). The 5-year overall survival (OS) rate was 77.68% in 5-FU implants group and 64.87% in control (p = 0.0159). Both the 5-years OS and PFS rates in 5-FU group were better than control group without significant side effect.Conclusions: 5-FU implants may improve 5-years OS and PFS rates after surgery in gastric cancer patients, while good safety profile suggests it could be reliable.

scholarly journals Low value of whole-body dual-modality [18f]fluorodeoxyglucose positron emission tomography/computed tomography in primary staging of stage I–II nasopharyngeal carcinoma: a nest case-control study

2021 ◽  
Author(s):  
Bei-Bei Xiao ◽  
Qiu-Yan Chen ◽  
Xue-Song Sun ◽  
Ji-Bin Li ◽  
Dong-hua Luo ◽  
...  
Keyword(s):  
Overall Survival ◽  
Lymph Node ◽  
Lymph Nodes ◽  
Stage I ◽  
Relapse Free Survival ◽  
Retropharyngeal Lymph Node ◽  
Free Survival ◽  
Pet Ct ◽  
Pre Treatment

Abstract Objectives The value of using PET/CT for staging of stage I–II NPC remains unclear. Hence, we aimed to investigate the survival benefit of PET/CT for staging of early-stage NPC before radical therapy. Methods A total of 1003 patients with pathologically confirmed NPC of stages I–II were consecutively enrolled. Among them, 218 patients underwent both PET/CT and conventional workup ([CWU], head-and-neck MRI, chest radiograph, liver ultrasound, bone scintigraphy) before treatment. The remaining 785 patients only underwent CWU. The standard of truth (SOT) for lymph node metastasis was defined by the change of size according to follow-up MRI. The diagnostic efficacies were compared in 218 patients who underwent both PET/CT and CWU. After covariate adjustment using propensity scoring, a cohort of 872 patients (218 with and 654 without pre-treatment PET/CT) was included. The primary outcome was overall survival based on intention to treat. Results Retropharyngeal lymph nodes were metastatic based on follow-up MRI in 79 cases. PET/CT was significantly less sensitive than MRI in detecting retropharyngeal lymph node lesions (72.2% [62.3–82.1] vs. 91.1% [84.8–97.4], p = 0.004). Neck lymph nodes were metastatic in 89 cases and PET/CT was more sensitive than MRI (96.6% [92.8–100.0] vs. 76.4% [67.6–85.2], p < 0.001). In the survival analyses, there was no association between pre-treatment PET/CT use and improved overall survival, progression-free survival, local relapse-free survival, regional relapse-free survival, and distant metastasis-free survival. Conclusions This study showed PET/CT is of little value for staging of stage I–II NPC patients at initial imaging. Key Points • PET/CT was more sensitive than MRI in detecting neck lymph node lesions whereas it was significantly less sensitive than MRI in detecting retropharyngeal lymph node lesions. • No association existed between pre-treatment PET/CT use and improved survival in stage I–II NPC patients.

scholarly journals A Cross Sectional Study on Loco-Regional Recurrences and Overall Survival Rate among Patients with Stage II (T2N0M0) Glottis Carcinoma Treated with Chemoradiation and Surgery

2021 ◽  
Vol 8 (04) ◽  
pp. 219-223
Author(s):  
Niharika Darasani
Keyword(s):  
Overall Survival ◽  
Survival Rate ◽  
Squamous Cell ◽  
Stage Ii ◽  
Overall Survival Rate ◽  
Disease Specific Survival ◽  
Free Survival ◽  
Tertiary Teaching ◽  
Voice Preservation ◽  
Disease Specific

BACKGROUND Single modality treatment for stage I and stage II squamous cell carcinomas of glottis region gave excellent results. Since a long time these are treated either with definitive radiation therapy or surgical excision with endoscopes. There was not much difference with regard to voice preservation, local recurrence and disease-free survival period. Our aim was to study the clinical presentation and management protocol of glottis carcinoma in a tertiary hospital and observe the final outcome of stage II (T2N0M0) glottis carcinoma and specific factor for survival in patients treated with surgery, radiotherapy and concurrent chemoradiation. METHODS 43 patients of glottis carcinoma stage II (T2N0M0) attending a tertiary teaching hospital between May 2015 and April 2017 were included in the study. Demography and smoking status of subjects were recorded. Staging of the disease was according to American Joint Committee on Cancer (AJCC) Staging System 7th edition. Paraglottic space infiltration was taken as a criteria to upgrade the staging. The overall survival rate, recurrence free survival, disease specific survival rate and laryngeal function preservation rate were calculated. RESULTS Out of 43 patients, males were 90.69 % and 09.30 % were females. Male to female ratio was 10.57 : 1. Mean age was 58.62 ± 2.35 years. 67.44 % were current smokers, 27.90 % were former smokers and 02.32 % were non-smokers. The overall survival scores and disease specific survival was 100 % with 11.62 % locoregional recurrences. The voice preservation was 86.04 %. Radiotherapy was used in 72.09 %, chemoradiation in 18.60 % patients and 11.62 % patients underwent surgery. 11.62 % patients presented with locoregional recurrence during 24 months of follow up. 02.32 % patients had to undergo tracheostomy. CONCLUSIONS The overall survival scores and disease specific survival were 100 % with 11.62 % loco-regional recurrence. Voice preservation was 86.04 %. Proactive prevention rather than escalation of treatment protocol gives better prognosis. KEYWORDS Glottis, Larynx, Supra Glottis, Sub Glottis, Squamous Cell Carcinoma, Chemo Radiation and Trans Oral Laryngeal Surgeries

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