Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: a phase II study.

Gasparini, G; Caffo, Orazio; Barni, Sandro; Frontini, L.; Testolin, A.; Guglielmi, Rosabianca; Ambrosini, G.

doi:10.1200/jco.1994.12.10.2094

Cited by 149 publications

(57 citation statements)

References 18 publications

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“…In all of these studies, treatment was well tolerated, with neutropenia being the most frequent and dose-limiting toxicity. Based on these results and documented activity of single-agent vinorelbine in second-line chemotherapy (Gasparini et al, 1994;Degardin et al, 1994), a substantial activity for combination regimens including this agent would be anticipated, and preliminary results seem to confirm these expectations (Spielmann et al, 1994;Fabi et al, 1995;Nole et al, 1995).…”

supporting

confidence: 54%

Effective treatment of advanced breast cancer with vinorelbine, mitomycin C plus human granulocyte colony-stimulating factor

Kornek

Haider²,

Kwasny³

et al. 1996

Br J Cancer

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Summary A phase II trial was performed to evaluate the efficacy and tolerance of vinorelbine (VNB), mitomycin C (MMC), and recombinant human granulocyte colony-stimulating factor (G-CSF) in advanced breast cancer. Between October 1992 and July 1994, 55 patients entered this trial. Nine patients had locally advanced disease and 46 had distant metastases, including 14 who had received previous palliative chemotherapy with (n = 9) or without anthracyclines (n = 5). Therapy consisted of VNB 40 -50 mg m-2 diluted in 250 ml saline infused over 30 min every 3 weeks, and MMC 15 mg m-2 administered by intravenous bolus injection every 6 weeks. G-CSF was given at 5 pg kg-' day-' subcutaneously from days 2 to 7 following each cytotoxic drug administration. Treatment was continued in case of response or stable disease for a total of six courses. The overall response rate was 73% for all 55 patients (95% confidence interval, 59-84%), including 12 (22%) complete response (CR) and 28 (51 %) partial response (PR); 13 patients (24%) had stable disease (SD), and only two (4%) progressed. All nine patients with locally advanced disease were rated responsive (two pCR, seven PR) and underwent surgery with curative intent. Eight out of nine remain disease free after a median observation period of 18 months (range, 13.5-28 months). Among the 32 previously untreated patients with metastatic disease, nine (28%) achieved CR, 15 PR (47%), seven SD (22%) and one PD (3%). Second-line chemotherapy with this regimen resulted in 7/14 (50%) objective remissions (one CR, six PR), six had SD and one PD. The median time to progression was 12 months (range, 2-24+months) in previously untreated patients with disseminated disease, and 6.0 months (range, 2 -22 months) in those who had failed prior chemotherapy. After a median follow-up time of 20 months, 24 patients with distant metastases are still alive with disease; median survival has not been reached yet. The dose-limiting toxicity was myelosuppression: six (11 %) and ten patients (18%) had World Health Organization grade 3, and eight (14%) and nine patients (16%) had grade 4 leucopenia and granulocytopenia respectively. Severe (WHO grade 3) non-haematological toxicities included nausea/ vomiting in 7%, constipation in 9%, peripheral neuropathy in 5%, infectious episodes in 7%, phlebitis due to drug extravasation in 5%, alopecia in 9%, and acute reversible pulmonary toxicity in 11 %. Our data suggest that vinorelbine, mitomycin C plus G-CSF has an excellent anti-tumour activity in advanced breast cancer, probably superior to most other available combination chemotherapy regimens. This combination does not seem to present significant cross-resistance with previous CMF or anthracycline regimens. Apart from reversible, acute pulmonary toxicity, a rare adverse reaction that had previously been described for VNB, as well as the combination of natural vinca alkaloids with mitomycin C, and few episodes of grade 3 neurotoxicity (all of which occurred at the initial 50 mg m 2 VNB dose level), the toleranc...

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supporting

confidence: 54%

Effective treatment of advanced breast cancer with vinorelbine, mitomycin C plus human granulocyte colony-stimulating factor

Kornek

Haider²,

Kwasny³

et al. 1996

Br J Cancer

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“…[11][12][13][14][15][16] The dose-limiting toxic effect of weekly vinorelbine is neutropenia. Nonhematologic toxic effects are usually mild and include neurotoxicity, constipation, pain at the injection site, phlebitis, nausea, and asthenia.…”

mentioning

confidence: 99%

Phase I study of vinorelbine and paclitaxel by 3‐hour simultaneous infusion with and without granulocyte colony‐stimulating factor support in metastatic breast carcinoma

Ibrahim

Buzdar

Valero

et al. 2001

Cancer

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“…especially. administration of high doses of chemotherapy with or without autologous bone marrow or peripheral stem cell transplantation seem encouraging (Ayash et al 1994: Hayes et al 1995 (Cannobio et al 1989: Garcia-Conde et al 1992: Degardin et al 1994: Fumoleau et al 1994: Gasparini et al 1994: Romero et al 1994: Touissant et al 1994: Weber et al 1995. substantial activity for combination regimens including this agent would be anticipated.…”

Section: Discussionmentioning

confidence: 99%

“…Given as a single agent. the drug yields response rates of 37-60% in previously untreated patients (Cannobio et al 1989: Garcia-Conde et al 1992: Romero et al 1994: Toussaint et al 1994: Fumoleau et al 1994: Weber et al 1995 and of about 30% when used as second-line therapy or salvage chemotherapy (Degardin et al 1994: Gasparini et al 1994. In all of these studies.…”

mentioning

confidence: 99%

Effective treatment of advanced breast cancer with vinorelbine, 5-fluorouracil and l-leucovorin plus human granulocyte colony-stimulating factor

Kornek

Haider²,

Kwasny³

et al. 1998

Br J Cancer

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Summary A phase 11 trial was performed to investigate the efficacy and tolerance of vinorelbine (VNB), 5-fluorouracil (5-FU), I-leucovorin (LLV) and recombinant human granulocyte colony-stimulating factor (G-CSF) in advanced breast cancer. Between August 1994 and October 1996, 53 patients entered this trial. Thirty-seven patients were previously untreated and 16 patients had failed previous palliative chemotherapy with (n = 12) or without anthracyclines (n = 4). Therapy consisted of VNB 40 mg m-2 diluted in 250 ml of saline infused over 30 min on days 1 and 14 and LLV 100 mg m-2 administered by intravenous bolus injection and 5-FU 400 mg m-2 diluted in 500 ml of saline infused over 2 h, both given on days 1-5 every 4 weeks. G-CSF was administered at 5 9g kg-' day-' subcutaneously on days 6-10 during each cycle. Treatment was continued in cases of response or stable disease until a total of six courses were completed. The overall response rate was 59% for chemotherapeutically naive patients (95% confidence interval 42-75%), including five complete responses (CR; 13%) and 17 partial responses (PR; 46%); ten patients (27%/6) had stable disease (SD) and only five (14%) progressed (PD). Second-line chemotherapy with this regimen resulted in 3/16 (19%) objective remissions, but nine patients had SD and four had PD. The median time to progression was 10.5 months (range 2-23) in previously untreated patients and 7.0 months (range 2-19) in those who had failed prior chemotherapy. After a median follow-up time of 14 months, 29 patients (55%) are still alive with metastatic disease; median survival has not been reached yet. The dose-limiting toxicity was myelosuppression: WHO grade IlIl and IV neutropenia occurred in 15 (28%) and four patients (8%), and was complicated by septicaemia in two; grade IlIl anaemia and thrombocytopenia were noted in four (8%) and three (6%) patients respectively. Severe (WHO grade 3) non-haematological toxicitles included stomatitis in 6% and nausea/vomiting and alopecia in 2% each. Our data suggest that the combination of vinorelbine, 5-fluorouracil and 1-leucovorin plus G-CSF is an effective first line regimen for treatment of advanced breast cancer. Overall toxicity was modest, with myelosuppression being the dose-limiting side-effect. Other severe adverse reactions were uncommon.

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Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: a phase II study.

Cited by 149 publications

References 18 publications

Effective treatment of advanced breast cancer with vinorelbine, mitomycin C plus human granulocyte colony-stimulating factor

Effective treatment of advanced breast cancer with vinorelbine, mitomycin C plus human granulocyte colony-stimulating factor

Phase I study of vinorelbine and paclitaxel by 3‐hour simultaneous infusion with and without granulocyte colony‐stimulating factor support in metastatic breast carcinoma

Effective treatment of advanced breast cancer with vinorelbine, 5-fluorouracil and l-leucovorin plus human granulocyte colony-stimulating factor

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