Doxorubicin-Docetaxel Sequential Schedule: Results of Front-Line Treatment in Advanced Breast Cancer

Introduction: Integration of patient preferences into shared decision making improves disease-related outcomes, but such data from patients with advanced breast cancer (aBC) are limited. The objective of this study was to demonstrate the relative importance of overall survival (OS) and progression-free survival (PFS) in relation to quality of life (QoL) and therapy-associated side effects from the perspective of patients with aBC. Methods: Postmenopausal patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative aBC receiving first- or second-line treatment were recruited throughout Germany. Patient-relevant attributes for aBC therapy assessment were collected using a stepwise multimodal approach. A conjoint matrix was developed, resulting in 2 attributes for therapy goals (OS and PFS), 4 for QoL, and 6 for side effects. An online quantitative survey was then performed using adaptive choice-based conjoint (ACBC) methodology. Results: The quantitative survey included 104 patients: 67 (64.4%) receiving first-line treatment and 37 (35.6%) receiving second-line treatment. The QoL attribute “physical agility and mobility” received the highest utility score (19.4 of 100%), reflecting the greatest importance to patients, followed by treatment goals (OS [15.2%] and PFS [14.4%]). Therapy-related side effects were less important, with nausea/vomiting being the most important (9.3%), followed by infection (6.4%) and hair loss (5.0%). The McFadden pseudo R2 (0.805), the root likelihood (0.864), and the χ2 test (2,809.041; p < 0.0001) indicated a very good fit of the statistical model. Conclusion: Using ACBC analysis, it appears that QoL, OS, and PFS are most important to postmenopausal patients with aBC in relation to cancer treatment. Side effects seem to be less important if OS or PFS are prolonged and the QoL is maintained. Thus, QoL, OS, and PFS should be considered equally when making treatment decisions in aBC.

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362 Aminoglutethimide + hidrocortisone (AMG + HC) vs. megestrol acetate (MEG) as second and third line treatment in advanced breast cancer (ABC): A phase III study

European Journal of Cancer ◽

10.1016/0959-8049(95)95615-d ◽

1995 ◽

Vol 31 ◽

pp. S79

Author(s):

A.F. Lacave ◽

F. Arranz ◽

A.S. Rubiales ◽

F.M. Buesa ◽

E. Estrada ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Advanced Breast ◽

Megestrol Acetate ◽

Phase Iii ◽

Line Treatment ◽

Phase Iii Study ◽

Third Line ◽

Third Line Treatment

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Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting

Investigational New Drugs ◽

10.1007/s10637-019-00890-5 ◽

2020 ◽

Vol 38 (5) ◽

pp. 1540-1549

Author(s):

Kenichi Inoue ◽

Masato Takahashi ◽

Hirofumi Mukai ◽

Takashi Yamanaka ◽

Chiyomi Egawa ◽

...

Keyword(s):

Breast Cancer ◽

Observational Study ◽

Confidence Interval ◽

Advanced Breast Cancer ◽

Advanced Breast ◽

Line Treatment ◽

Second Line ◽

Treatment Groups ◽

Post Marketing ◽

Grade 3

Summary Background Data on eribulin as the first- or second-line treatment in a clinical setting, especially the overall survival (OS) of patients, are scarce. Therefore, we assessed the effectiveness and safety of eribulin as the first-, second-, and third- or later-line treatments in patients with human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in Japan. Methods This multicenter, prospective, post-marketing, observational study enrolled patients from September 2014 to February 2016 in Japan and followed them for 2 years. Patients were categorized by eribulin use into the first-, second-, and third- or later-line treatment groups. Results Of 651 registered patients, 637 patients were included in the safety and effectiveness analysis. In all, first-, second-, and third or later-line treatment groups, median OS (95% confidence interval) were 15.6 (13.8–17.6), 22.8 (17.3–31.0), 16.3 (12.4–19.9), and 12.6 (11.2–15.1) months and time to treatment failure (TTF) (95% confidence interval) were 4.2 (3.7–4.4), 5.2 (3.7–5.9), 4.2 (3.7–5.1), and 3.8 (3.5–4.2) months, respectively. Prolonged TTF was associated with complications of diabetes and the development of peripheral neuropathy after eribulin treatment, according to multivariate Cox regression analysis. Grade ≥ 3 adverse drug reactions (ADRs) were reported in 61.7% of the patients. Neutropenia (49.5%) was the most common grade ≥ 3 ADR in all groups. Conclusions The effectiveness and safety results of eribulin as the first- or second-line treatment were favorable. Thus, these suggest eribulin may be a first-line treatment candidate for patients with HER2-negative advanced breast cancer in Japan.

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Weekly Docetaxel in the Treatment of Elderly Patients With Advanced Breast Cancer: A Minnie Pearl Cancer Research Network Phase II Trial

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.15.3500 ◽

2001 ◽

Vol 19 (15) ◽

pp. 3500-3505 ◽

Cited By ~ 126

Author(s):

John D. Hainsworth ◽

Howard A. Burris ◽

Denise A. Yardley ◽

James E. Bradof ◽

Manuel Grimaldi ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Advanced Breast Cancer ◽

Performance Status ◽

Metastatic Breast ◽

Poor Performance ◽

Advanced Breast ◽

Poor Performance Status ◽

Line Treatment ◽

Weekly Docetaxel

PURPOSE: To evaluate the efficacy and toxicity of docetaxel administered weekly to elderly or poor-performance status patients with advanced breast cancer. PATIENTS AND METHODS: Forty-one patients with advanced breast cancer who were either over the age of 65 or considered to be poor candidates for combination chemotherapy received docetaxel 36 mg/m2 weekly for 6 consecutive weeks, followed by 2 weeks without treatment. The median age of patients in this trial was 74 years, and 73% of patients had one or more visceral sites of metastases. Seventy-five percent of patients received weekly docetaxel as first-line treatment for metastatic breast cancer, and the other 25% received it as second-line treatment. Thirty-six patients were assessable for efficacy, and all patients were assessed for toxicity. RESULTS: A total of 448 doses of weekly docetaxel were administered to 41 patients. Thirteen patients (36%) had objective responses to treatment, and an additional 13 patients (36%) had stable disease or minor response. Median time to progression for responding and stable patients was 7 months (range, 3 to 27 months). Median survival for the entire group was 13 months, with 1- and 2-year actuarial survival rates of 61% and 29%, respectively. Severe neutropenia occurred in only 0.4% of courses, and no other hematologic toxicity was observed. Grade 3/4 fatigue was the most common toxicity, occurring in 20% of patients. CONCLUSION: Weekly docetaxel therapy is active and well tolerated by elderly and/or poor-performance status patients with advanced breast cancer. This treatment can be administered with minimal myelosuppression. Weekly docetaxel provides an additional option for treatment in this difficult subgroup of patients with metastatic breast cancer. Well-tolerated combination regimens containing weekly docetaxel merit evaluation for this patient population.

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Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1995.13.11.2722 ◽

1995 ◽

Vol 13 (11) ◽

pp. 2722-2730 ◽

Cited By ~ 130

Author(s):

B L Weber ◽

C Vogel ◽

S Jones ◽

H Harvey ◽

L Hutchins ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Single Agent ◽

Objective Response ◽

Advanced Breast ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

Line Therapy

PURPOSE We evaluated single-agent intravenous (IV) vinorelbine as first- and second-line treatment for advanced breast cancer (ABC) in patients who were not resistant to anthracyclines. Objective tumor response (TR) and toxicity were assessed. PATIENTS AND METHODS A total of 107 women were enrolled onto this multicenter, nonrandomized, open-label phase II study. Patients were stratified into first- and second-line treatment groups, based on prior treatment history. Vinorelbine was initially given at 30 mg/m2/wk, with dose modification for toxicity as indicated. Therapy was continued until disease progression or severe toxicity mandated withdrawal or until the patient asked to be removed from the study. RESULTS The objective response rate for all patients was 34% (95% confidence interval [CI], 25% to 44%): 35% (95% CI, 23% to 48%) for first-line patients and 32% (95% CI, 20% to 47%) for second-line patients. Nine first-line and three second-line patients obtained a complete response (CR). The median duration of objective response was 34 weeks in both groups. The overall survival durations of first- and second-line patients were 67 weeks and 62 weeks, respectively. Granulocytopenia was the predominant dose-limiting toxicity. Two patients died on study as a result of granulocytopenic sepsis. CONCLUSION Single-agent vinorelbine is an effective and well-tolerated agent for first- and second-line therapy of ABC. The results of this study confirm the findings of similar international trials and suggest vinorelbine should be considered a valid treatment option for patients with ABC and a potential component in future combination regimens for this disease.

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