Survival Benefit with Capecitabine/Docetaxel Versus Docetaxel Alone: Analysis of Therapy in a Randomized Phase III Trial

Miles, David; Vukelja, Svetislava J.; Moiseyenko, Vladimir; Cervantes, Guadalupe; Mauriac, L.; Hazel, G. Van; Liu, Wing-Yiu; Ayoub, Jean-Pierre; O’Shaughnessy, Joyce

doi:10.3816/cbc.2004.n.030

Cited by 55 publications

(43 citation statements)

References 11 publications

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“…These results compare favourably with randomised phase III trials of 1st-line chemotherapy for MBC, in which 30–56% of the patients did not receive 2nd-line chemotherapy [24,25,26,27,28,29]. The high proportion of patients receiving capecitabine followed at progression by taxane-based therapy supports the findings of the Mexican Oncology Study Group trial performed in anthracycline-pretreated MBC [15].…”

Section: Discussionsupporting

confidence: 76%

First-Line Capecitabine Monotherapy for Slowly Progressing Metastatic Breast Cancer: Do We Need Aggressive Treatment?

Debled

Madranges²,

Trainaud³

et al. 2009

Oncology

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Background: Primary treatment goals in less aggressive metastatic breast cancer (MBC) are prolonged survival, good quality of life and control of the disease and its symptoms. High activity, oral administration and no alopecia make capecitabine monotherapy attractive in slowly evolving disease. Methods: We retrospectively analysed 226 patients who had received single-agent capecitabine as 1st-line chemotherapy at our institution. Results: The median interval between breast cancer diagnosis and MBC was 52 months (range 0–479); 76% had received endocrine therapy for MBC, 58% had visceral involvement and 30% had 3 or more metastatic sites. The median starting dose was 1,000 mg/m² twice daily. Disease was improved in 56% of the patients (median duration: 13.2 months) and stabilised in 20%. Median time to treatment failure was 8.8 months (95% CI: 7.1–10.5); median overall survival from initiating capecitabine was 23.6 months (95% CI: 19.7–27.4). Prior adjuvant chemotherapy, endocrine therapy for MBC, visceral disease, hormone receptor status and initial capecitabine dose did not influence time to treatment failure. Among 161 patients <75 years, 90% received further chemotherapy. Conclusion: Based on these findings, 1st-line capecitabine should be considered in slowly progressing disease, offering an active, well-tolerated oral treatment with minimal toxicity and no alopecia. More toxic treatments may be reserved for more aggressive disease.

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Section: Discussionsupporting

confidence: 76%

First-Line Capecitabine Monotherapy for Slowly Progressing Metastatic Breast Cancer: Do We Need Aggressive Treatment?

Debled

Madranges²,

Trainaud³

et al. 2009

Oncology

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“…The association of capecitabine and docetaxel demonstrated highly effective disease control and an established survival benefit compared with docetaxel alone and it seems to be particularly suited to patients with rapidly progressing disease [11, 12]. Less mature, but also encouraging, are data on regimens including capecitabine in combination with paclitaxel [9, 10] and vinorelbine [22,23,24].…”

Section: Discussionmentioning

confidence: 99%

“…A response rate of 51% was observed in patients receiving first-line treatment with this combination[9] and 52% in anthracycline-pretreated patients [10]. The combination of capecitabine and docetaxel for advanced breast cancer patients pretreated with anthracyclines showed a clear superior survival compared to docetaxel alone, although with this regimen a high rate of grade 3–4 toxicities has been reported [11, 12]. …”

Section: Introductionmentioning

confidence: 99%

Capecitabine and Mitomycin C Is an Effective Combination for Anthracycline- and Taxane-Resistant Metastatic Breast Cancer

Massacesi¹,

Cesa

Marcucci³

et al. 2006

Oncology

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Capecitabine is converted to 5-fluorouracil by thymidine phosphorylase, and mitomycin C is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect. Fifty-three patients (median age 62 years) with anthracycline- and taxane-resistant, metastatic breast cancer received mitomycin C 6 mg/m² on day 1, and capecitabine (Xeloda) 2,000 mg/m²/day from day 1 to day 14 with cycles repeated every 4 weeks. Overall, 77.4% had visceral metastases and 33 were pretreated with ≧3 chemotherapy lines. A median of 6 cycles were given (range 1–19) with a complete response observed in 2 patients (3.9%), partial response in 17 (33.3%) and stable disease in 19 (37.2%). Overall response rate was 37.2% (95% CI, 24.0–50.5%), with a median duration of 10.4 months. Median time to progression was 8.1 months and median survival was 17.4 months (1- and 2-year survival rates of 60 and 28%, respectively). Toxicity was mild. The most frequent grade 3/4 events were neutropenia (5.7% of patients), diarrhea (3.8%), and deep venous thrombosis (3.8%). Capecitabine plus mitomycin C may represent an effective and manageable treatment option for advanced breast cancer patients resistant to anthracyclines and taxanes. This approach provides an alternative for pretreated patients with advanced breast cancer.

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“…The capecitabine plus docetaxel (XT) combination demonstrated significantly superior time to progression and OS versus docetaxel alone in the pivotal phase III metastatic breast cancer trial (15,16).…”

Section: Introductionmentioning

confidence: 99%

Patients with Slowly Proliferative Early Breast Cancer Have Low Five-Year Recurrence Rates in a Phase III Adjuvant Trial of Capecitabine

O’Shaughnessy

Koeppen²,

Xiao³

et al. 2015

Clinical Cancer Research

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Purpose: We conducted a randomized phase III study to determine whether patients with early breast cancer would benefit from the addition of capecitabine (X) to a standard regimen of doxorubicin (A) plus cyclophosphamide (C) followed by docetaxel (T).Experimental Design: Treatment comprised eight cycles of AC!T (T dose: 100 mg/m 2 on day 1) or AC!XT (X dose: 825 mg/m 2 twice daily, days 1-14; T dose: 75 mg/m 2 on day 1). The primary endpoint was 5-year disease-free survival (DFS).Results: Of 2,611 women, 1,304 were randomly assigned to receive AC!T and 1,307 to receive AC!XT. After a median follow-up of 5 years, the study failed to meet its primary endpoint [HR, 0.84; 95% confidence interval (CI), 0.67-1.05; P ¼ 0.125]. A significant improvement in overall survival, a secondary endpoint, was seen with AC!XT versus AC!T (HR, 0.68; 95% CI, 0.51-0.92; P ¼ 0.011). There were no unexpected adverse events. Of patients with estrogen receptor (ER)-positive/HER2-negative disease, 70% of whom were node-positive, 26% and 59% had tumors with a centrally assessed Ki-67 score of <10% or <20%, respectively, and only 17 (2%) and 53 (6%) DFS events, respectively, occurred in these groups at 7 years.Conclusions: The very low event rate in patients with ERpositive, low Ki-67 cancers, regardless of nodal status, strongly suggests that these patients should not be enrolled in adjuvant trials that assess 5-year DFS rates and that central Ki-67 analyses can identify these patients.

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Survival Benefit with Capecitabine/Docetaxel Versus Docetaxel Alone: Analysis of Therapy in a Randomized Phase III Trial

Cited by 55 publications

References 11 publications

First-Line Capecitabine Monotherapy for Slowly Progressing Metastatic Breast Cancer: Do We Need Aggressive Treatment?

First-Line Capecitabine Monotherapy for Slowly Progressing Metastatic Breast Cancer: Do We Need Aggressive Treatment?

Capecitabine and Mitomycin C Is an Effective Combination for Anthracycline- and Taxane-Resistant Metastatic Breast Cancer

Patients with Slowly Proliferative Early Breast Cancer Have Low Five-Year Recurrence Rates in a Phase III Adjuvant Trial of Capecitabine

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