Gemcitabine and vinorelbine as second-line treatment in patients with metastatic breast cancer: a phase II study

Abstract

Vinorelbine and gemcitabine is a manageable scheme with moderate activity in pretreated patients with advanced breast cancer.

Gemcitabine and Vinorelbine Combination Chemotherapy in Taxane-Pretreated Patients with Metastatic Breast Cancer: A Phase II Study of the Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015

“…Grade 3 and 4 neutropenia was observed in 22 patients (52%), consistent with previous reports [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. Although the incidence of neutropenia in the combination therapy was higher than in capecitabine or vinorelbine monotherapy [34,37], the incidence of febrile neutropenia was considerably low, ranging from 0 to 11% [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27], and it would not be associated with infective complications. The compliance with the protocol observed in our trial was favorable, due to the reasonable dose intensity and moderate toxicity.…”

“…In addition, most of the patients experienced grade 1 or 2 nonhematologic adverse events, and no severe event was reported. The toxicological profiles and findings in our results were tolerable and similar to those reported previously [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. …”

“…Phase II studies demonstrated that the combination chemotherapy has favorable activity, but most of these were nonrandomized, single-arm studies [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. Several randomized phase II and III studies have been conducted for MBC patients evaluating the combination therapy versus monotherapy or sequential therapy, and they reported conflicting results [34,35,36,37].…”

“…These characteristics can make the combination regimen effective for MBC patients pretreated with taxanes or anthracyclines. Several phase II studies have investigated using the combination regimen for various lines of treatment of MBC patients [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]. The ORR in these studies ranged from 20 to 55%, PFS ranged from 3.5 to 10.8 months, and OS ranged from 9.2 to 20 months.…”

Gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer

“…Gemcitabine and vinorelbine, either alone or in combination, have shown activity in metastatic breast cancer (MBC) pretreated by anthracycline and taxane [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21]. Single agent gemcitabine can achieve disease control rate of 35%, median progression-free survival (PFS) of 4.5 months and median overall survival (OS) of 9.8 months on relapsing or failing of both anthracycline and taxane [6].…”