Final results of a randomized phase III trial of docetaxel, carboplatin and 5FU versus epirubicin, cisplatin and 5FU for locally advanced gastric cancer

Elsaid, A.; Elkerm, Yasser

doi:10.1200/jco.2005.23.16_suppl.4014

Cited by 16 publications

(17 citation statements)

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“…The median number of cycles was 11 (2-34), with 33 patients (76.7%) receiving 7 or more cycles. Despite 11 patients (25.6%) coming off treatment because of adverse events, the median number of cycles among these patients was eight (range, [5][6][7][8][9][10][11][12][13][14][15][16][17][18], with cumulative sensory neuropathy as the most common toxicity leading to discontinuation. These results compare favorably with other modified triplet regimens that have been subsequently published, such as modified DCF, docetaxel with 5-FU and carboplatin, epirubicin with oxaliplatin and 5-FU, and TEF (docetaxel, oxaliplatin, and 5-FU; Fig.…”

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confidence: 99%

Docetaxel, Oxaliplatin, and 5-Fluorouracil (DOF) in Metastatic and Unresectable Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Study with Long-Term Follow-Up

et al. 2019

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Lessons Learned. Adding docetaxel to the modified FOLFOX7 backbone (DOF) is a feasible three‐drug combination therapy for advanced gastric cancer with high activity, providing evidence that leucovorin is not necessary in this setting. The DOF regimen represents an alternative to the FLOT (5‐FU 2,600 mg/m 2 as 24‐hour infusion with leucovorin 200 mg/m 2 , oxaliplatin 85 mg/m 2 , and docetaxel 50 mg/m 2 ) regimen that can be considered in select patients with advanced gastric cancer and is a potential choice in the curative setting. Background. The combination of docetaxel, cisplatin, and 5‐fluorouracil (5‐FU) demonstrates high response rates in advanced gastric cancer, albeit with increased toxicity. Given the efficacy of platinum‐taxane‐fluoropyrimidine regimens, this phase II study evaluated the efficacy and toxicity of docetaxel, oxaliplatin, and 5‐FU (DOF) for the treatment of metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. Methods. Patients with metastatic or unresectable gastric or GEJ adenocarcinoma with no prior therapy for metastatic disease received docetaxel 50 mg/m 2 on day 1, oxaliplatin 85 mg/m 2 on day 1, and 5‐FU 2,400 mg/m 2 continuous intravenous infusion over 46 hours; cycles were repeated every 2 weeks. The primary endpoint was overall response rate (ORR). Results. Forty‐four patients were enrolled. Assessment of treatment response and toxicity was feasible in 41 and 43 patients, respectively. ORR was 73.2% (68.3% partial response; 4.9% complete response). Therapy was discontinued for progressive disease in 53%, toxicity in 26%, and death on treatment in 16%. Two patients underwent surgical resection. Thirty‐three patients (76.7%) received at least seven cycles (7–34). Grade 3–4 toxicities occurred in 31 patients (72.1%), including neutropenia (23.3%), neurologic (20.9%), and diarrhea (14.0%). Median overall survival was 10.3 months. Conclusion. DOF demonstrates a high response rate, expected safety profile, and prolonged survival and remains an option for select patients with unresectable or metastatic gastric or GEJ adenocarcinoma.

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confidence: 99%

Docetaxel, Oxaliplatin, and 5-Fluorouracil (DOF) in Metastatic and Unresectable Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Study with Long-Term Follow-Up

et al. 2019

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“…Carboplatin has shown marginal activity in patients with stomach cancer, with response rates of 6-10% as a single agent [18,19], while cisplatin as a single agent has shown response rates of 18% [9]. On the other hand, in a randomized study from Egypt, the combination of docetaxel/carboplatin/5-FU was compared with the ECF regimen in 64 patients and showed response rate of 66.7% vs. 47.1% and improved overall survival (12.4 months vs. 8.7 months) [20]. However, the number of patients in that trial was too small for a definitive conclusion.…”

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confidence: 93%

Intensive weekly chemotherapy with docetaxel, epirubicin and carboplatin with G-CSF support in patients with advanced gastric cancer

et al. 2007

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Chemotherapy is an established modality in the management of patients with advanced gastric cancer but the optimal regimen has not been defined yet. Platinum and the anthracyclines and more recently docetaxel have shown activity in this tumor. The primary objective of this phase II study was to assess the efficacy and safety of an intensified regimen of weekly docetaxel/epirubicin/carboplatin (DECb) with growth factor support in previously untreated patients with advanced gastric cancer. A total of 72 patients with measurable disease received docetaxel at a dose of 30 mg/m2, epirubicin at a dose of 30 mg/m2 and carboplatin to a target area under the curve (AUC) of 2, every week for 6 consecutive weeks followed by 2 weeks' rest, with filgrastim support. Analysis was performed on an intention to treat basis. The main toxicity was hematologic with grade 3/4 neutropenia occurring in 35% of the patients. Other grade 3/4 toxicities included anemia (7%), thrombocytopenia (14%) and leucopenia (26%). The relative dose intensity of docetaxel and epirubicin was 62%. The overall response rate was 21%, the median time to tumor progression was 4.1 months and the median survival 7.3 months. Intensified weekly treatment with DECb has modest activity in the treatment of advanced gastric cancer. Myelotoxicity limits adequate drug delivery.

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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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Final results of a randomized phase III trial of docetaxel, carboplatin and 5FU versus epirubicin, cisplatin and 5FU for locally advanced gastric cancer

Cited by 16 publications

References 0 publications

Docetaxel, Oxaliplatin, and 5-Fluorouracil (DOF) in Metastatic and Unresectable Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Study with Long-Term Follow-Up

Docetaxel, Oxaliplatin, and 5-Fluorouracil (DOF) in Metastatic and Unresectable Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Study with Long-Term Follow-Up

Intensive weekly chemotherapy with docetaxel, epirubicin and carboplatin with G-CSF support in patients with advanced gastric cancer

Systemic Therapy for Advanced Gastric Cancer: A Clinical Practice Guideline

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