NE Oncology Issue – June 2007


The combination of gemcitabine plus paclitaxel has been shown to be superior compared to paclitaxel alone as first-line chemotherapy for patients with metastatic breast cancer who have received prior (neo) adjuvant anthracycline therapy.1,2 Gemcitabine is a pyrimidine nucleoside antimetabolite with demonstrated antitumour activity in a variety of solid tumours, and a toxicity profile that does not overlap with other chemotherapeutic drugs. Roy and colleagues presented the results of their study on nab-paclitaxel and gemcitabine given in a novel combination schedule for first-line treatment of metastatic breast cancer.3

Study design

  • Fifty patients diagnosed with metastatic breast cancer, with a median age of 56 years (range, 29–86 years) and ECOG PS 0 or 1, were enrolled from 22 sites.
  • Patients had received no prior chemotherapy for metastatic disease. Prior hormonal therapy for metastatic breast cancer was allowed as was one adjuvant or neoadjuvant chemotherapy regimen. Previous adjuvant treatment with taxane was allowed if completed at least six months prior to study entry.
  • Patients with active brain metastasis and peripheral neuropathy > grade 1 were excluded from the study.
  • Gemcitabine was administered at a dose of 1,000 mg/m2, with nab-paclitaxel at a dose of 125 mg/m2, on days 1 and 8 of a 21-day cycle.

Key findings

  • There was no difference in response based on prior taxane treatment.
  • Dose delay occurred in 33 patients in 68 cycles, mostly due to hematologic adverse events (AEs).
  • Dose reduction was required in 29 patients in 53 cycles, mostly due to hematologic AEs.
  • Response rates, progression-free survival (PFS) (Figure 1), and overall survival (OS) are summarized in Table 1.
  • Adverse events are summarized in Table 2.

Key conclusions

  • Nab-paclitaxel in combination with gemcitabine demonstrated clear activity in patients with metastatic breast cancer.
  • Toxicities were manageable with neutropenia being the most common adverse event.
  • No significant non-hematologic toxicities were encountered.

References: 1. Albain K, Nag S, Calderillo-Ruiz G, et al. Global phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): First report of overall survival. Program and abstracts of the 40th American Society of Clinical Oncology Annual Meeting; June 5–8, 2004; New Orleans, Louisiana; Abstract 510. 2. Dent S, Messersmith H, Trudeau M, et al. Cancer Care Ontario. Evidence-based Series #1–12: Section 1. Current Report January 22, 2007. 3. Roy V, LaPlant BR, Gross GG, et al. NCCTG phase II trial N0531of weekly nab-paclitaxel (nab-p) in combination with gemcitabine (gem) in patients with metastatic breast cancer (MBC). Program and abstracts of the 43rd American Society of Clinical Oncology Annual Meeting; June 1–5, 2007; Chicago, Illinois; Abstract 1048.

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Vera Hirsh, MD, FRCPC
Chief of the Hematology-Oncology Service, Santa Cabrini Hospital
Associate Professor, Medicine and Oncology, McGill University
Associate Physician, Oncology Service, at the Royal Victoria, Montreal General, and Montreal Chest Hospitals
With a current practice in both hematology and oncology, Dr. Vera Hirsh is an associate professor of medicine and oncology at McGill University. Her research at the Quebec Pulmonary Unit focuses on the treatment of lung cancer, and she continues to chair ongoing international chemotherapy trials. Dr. Hirsh chaired the Quebec Lung Cancer Committee to establish guidelines for the treatment of lung cancer. In addition, she has published abstracts, articles, and book chapters. Dr. Hirsh is a member of advisory boards for many pharmaceutical companies and the Medical Oncology Standing Committee of RTOG.

Christine Cripps, MD, FRCPC
Medical Oncologist, Director,
Continuing Medical Education,
Ottawa Hospital Regional Cancer Centre
Dr. Christine Cripps is a medical oncologist and director of the Continuing Medical Education Department at the Ottawa Hospital Regional Cancer Centre. She also holds a position of Associate Professor, Medicine at the University of Ottawa. A keen teacher, Dr. Cripps’ main areas of interest include gastrointestinal cancer and head and neck cancer. She also enjoys cycling, skiing, and sailing when time permits.

Stephen K. L. Chia, MD, FRCPC
Assistant Professor of Medicine Department of Medicine
University of British Columbia
British Columbia Cancer Agency
Dr. Chia is a staff oncologist with the British Columbia Cancer Agency (BCCA), Vancouver, Canada. He also serves as physician coordinator for both the breast cancer and head and neck cancer clinical trials at the BCCA – Vancouver Cancer Centre. He is an active researcher in phase I-III trials in breast cancer, head and neck cancer and investigational new drugs. He is currently carrying out studies in breast cancer with grant funded research from the National Cancer Institute of Canada, Canadian Breast Cancer Alliance and Canadian Breast Cancer Foundation – British Columbia/Yukon Chapter. Dr. Chia is an active member of the British Columbia Breast Tumor Group, Breast Cancer Systemic Policy Group and Head and Neck Tumor Group.

José Chang, MD, FRCPC
Head of Medical Oncology, RS
McLaughlin Durham Regional Cancer Centre, Oshawa
Dr. José Chang is the principal investigator and site representative for the National Cancer Institute of Canada Clinical Trials Group, and is an examiner for the Medical Council of Canada. His research interests lie in the areas of breast cancer, melanoma, lymphoma, and quality of life during chemotherapy. Dr Chang has presented at major oncology meetings of the American Society of Clinical Oncology, San Antonio Breast Cancer Symposia, and European Breast Cancer Conference. A member of the editorial board of the journal Current Oncology, Dr. Chang has published in journals such as the Journal of Clinical Oncology, European Journal of Cancer, and Canadian Medical Association Journal.