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A Phase II Study of Sequential Capecitabine Plus Oxaliplatin Followed by Docetaxel Plus Capecitabine in Patients With Unresectable Gastric Adenocarcinoma

View Article: PubMed Central - PubMed

ABSTRACT

Fluorouracil and platinum are considered the standard treatment options for advanced gastric cancer. Docetaxel is also an effective agent and it shows no cross-resistance with fluorouracil and platinum. The combination treatment of docetaxel with fluorouracil and platinum has been explored, but it demonstrated intolerable toxicities. An alternative approach in the first-line treatment of gastric adenocarcinoma may be to use these agents sequentially. We aimed to evaluate the activity and safety profile of sequential chemotherapy with capecitabine plus oxaliplatin, followed by docetaxel plus capecitabine in the first-line treatment of unresectable gastric cancer.

We conducted a phase II study of sequential first-line chemotherapy in advanced gastric cancer. Treatment consisted of 6 cycles of capecitabine plus oxaliplatin (capecitabine 1000 mg/m2 bid on days 1–10 and oxaliplatin 85 mg/m2 on day 1, every 2 weeks), followed by 4 cycles of docetaxel plus capecitabine (docetaxel 30 mg/m2 on days 1 and 8, capecitabine 825 mg/m2 bid on days 1–14, every 3 weeks). The primary end-point was the objective response rate.

Fifty-one patients were enrolled: median age, 63 years; male/female: 37/14. The main grade 3 to 4 toxicities were a decreased absolute neutrophil count (25.4%), diarrhea (9.8%), and hand-foot syndrome (15.7%). The objective response rate was 61.7%. The median progression-free survival and overall survival were 8.6 and 11.0 months, respectively. Six patients (11.8%) received surgery after chemotherapy and 5 are still disease-free.

This sequential treatment demonstrated feasibility with a favorable safety profile and produced encouraging results in terms of activity and efficacy.

No MeSH data available.


Related in: MedlinePlus

Kaplan–Meier curves for progression-free survival of 47 advanced gastric cancer patients.
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Figure 2: Kaplan–Meier curves for progression-free survival of 47 advanced gastric cancer patients.

Mentions: Of the 51 patients, 47 were eligible for response evaluation. Four patients were not available for response evaluation: 1 was intolerant to capecitabine, 1 had disease progression and could not take oral drugs, and 2 patients were excluded at the investigator's discretion. Tumor responses are summarized in Table 3. During the XELOX regimen period, 25 patients (53.2%) achieved a partial response, 21 patients (44.7%) had stable disease, and 1 patient (2.7%) had disease progression. During the TX period, 8 patients (19.5%) achieved a partial response, 27 patients (65.9%) had stable disease, and 6 patients (14.6%) had disease progression. Overall, 29 patients (61.7%) achieved a partial response and 18 patients (38.3%) had stable disease. Among 8 patients who had response during the TX period, 5 patients had partial response, 2 patients had stable disease, and 1 patient had progressive disease during the XELOX period. The median PFS was 8.6 months (95% confidence interval [CI] 5.6–13.7 months, Figure 2), and the median OS was 11.0 months (95% CI 9.6–14.5 months, Figure 3). The median follow-up time was 10.1 months. Six patients (11.8%) completed treatment and their tumors became resectable. They underwent surgery and 5 of these patients were still alive with disease-free status during their last follow-up.


A Phase II Study of Sequential Capecitabine Plus Oxaliplatin Followed by Docetaxel Plus Capecitabine in Patients With Unresectable Gastric Adenocarcinoma
Kaplan–Meier curves for progression-free survival of 47 advanced gastric cancer patients.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4998286&req=5

Figure 2: Kaplan–Meier curves for progression-free survival of 47 advanced gastric cancer patients.
Mentions: Of the 51 patients, 47 were eligible for response evaluation. Four patients were not available for response evaluation: 1 was intolerant to capecitabine, 1 had disease progression and could not take oral drugs, and 2 patients were excluded at the investigator's discretion. Tumor responses are summarized in Table 3. During the XELOX regimen period, 25 patients (53.2%) achieved a partial response, 21 patients (44.7%) had stable disease, and 1 patient (2.7%) had disease progression. During the TX period, 8 patients (19.5%) achieved a partial response, 27 patients (65.9%) had stable disease, and 6 patients (14.6%) had disease progression. Overall, 29 patients (61.7%) achieved a partial response and 18 patients (38.3%) had stable disease. Among 8 patients who had response during the TX period, 5 patients had partial response, 2 patients had stable disease, and 1 patient had progressive disease during the XELOX period. The median PFS was 8.6 months (95% confidence interval [CI] 5.6–13.7 months, Figure 2), and the median OS was 11.0 months (95% CI 9.6–14.5 months, Figure 3). The median follow-up time was 10.1 months. Six patients (11.8%) completed treatment and their tumors became resectable. They underwent surgery and 5 of these patients were still alive with disease-free status during their last follow-up.

View Article: PubMed Central - PubMed

ABSTRACT

Fluorouracil and platinum are considered the standard treatment options for advanced gastric cancer. Docetaxel is also an effective agent and it shows no cross-resistance with fluorouracil and platinum. The combination treatment of docetaxel with fluorouracil and platinum has been explored, but it demonstrated intolerable toxicities. An alternative approach in the first-line treatment of gastric adenocarcinoma may be to use these agents sequentially. We aimed to evaluate the activity and safety profile of sequential chemotherapy with capecitabine plus oxaliplatin, followed by docetaxel plus capecitabine in the first-line treatment of unresectable gastric cancer.

We conducted a phase II study of sequential first-line chemotherapy in advanced gastric cancer. Treatment consisted of 6 cycles of capecitabine plus oxaliplatin (capecitabine 1000 mg/m2 bid on days 1–10 and oxaliplatin 85 mg/m2 on day 1, every 2 weeks), followed by 4 cycles of docetaxel plus capecitabine (docetaxel 30 mg/m2 on days 1 and 8, capecitabine 825 mg/m2 bid on days 1–14, every 3 weeks). The primary end-point was the objective response rate.

Fifty-one patients were enrolled: median age, 63 years; male/female: 37/14. The main grade 3 to 4 toxicities were a decreased absolute neutrophil count (25.4%), diarrhea (9.8%), and hand-foot syndrome (15.7%). The objective response rate was 61.7%. The median progression-free survival and overall survival were 8.6 and 11.0 months, respectively. Six patients (11.8%) received surgery after chemotherapy and 5 are still disease-free.

This sequential treatment demonstrated feasibility with a favorable safety profile and produced encouraging results in terms of activity and efficacy.

No MeSH data available.


Related in: MedlinePlus