Overall 278 patients were enrolled into the trial. Overall response rate was 34%(95%CL 26–42%) in the weekly VNR/CDDP arm, and 32%(95%CL 24–40%) in patients treated with day 1–8 VNR/CDDP without any statistically significant difference. Median TTP was 4.5 and 4.6 months respectively for weekly VNR/CDDP arm and the day 1–8 VNR/CDDP one. This difference was not statistically significant (log-rank test, p = 0.818). Median OS was 9.45 and 10 months respectively for weekly VNR/CDDP arm and the day 1–8 VNR/CDDP one without statistically a significant difference (log-rank test, p = 0.259). The 1- and 2-year survival rates were 31 and 36%, and 10 and 11%respectively. The incidence of severe neutropenia (34%versus 68%; p = 0.0001) and of febrile neutropenia (5%versus 12%; p = 0.026), as well as the rate of therapy omissions (10%versus 24%; p = 0.0037) were higher in the weekly VNR/CDDP arm than in the day 1–8 VNR/CDDP one. The weekly VNR/CDDP regimen was associated with a lower received dose intensity in a statistically significant fashion (9%versus 22%; p = 0.0001) and with a lower non-statistically significant quality of life score as compared to the day 1–8 VNR/CDDP schedule.
The combination of day 1–8 VNR plus CDDP every 3 weeks is less toxic and better tolerated than the regimen of weekly VNR plus CDDP every 4 weeks. The two schedules are equivalent in terms of overall response rate, median time-to-progression and overall survival. The combination of VNR on day 1–8 plus CDDP every 3 weeks may be considered as a reference regimen for the treatment of patients with advanced disease and those who deserve a postoperative therapy, and for future studies.
Purchase PDF (520 K) | Oral Vinorelbine May Not Induce Acute Pain at the Tumor... Journal of Pain and Symptom Management |
  Oral Vinorelbine May Not Induce Acute Pain at the Tumor SiteJournal of Pain and Symptom Management, Volume 32, Issue 3, September 2006, Pages 197-199 Paolo Tralongo, Anna Di Mari, Roberta Agueli, Vittorio Gebbia Purchase PDF (57 K) |
| Gemcitabine and cisplatin versus vinorelbine and cispla... Lung Cancer |
| Gemcitabine and cisplatin versus vinorelbine and cisplatin versus ifosfamide+gemcitabine followed by vinorelbine and cisplatin versus vinorelbine and cisplatin followed by ifosfamide and gemcitabine in stage IIIB–IV non small cell lung carcinoma: a prospective randomized phase III trial of the Gruppo Oncologico Italia Meridionale Lung Cancer, Volume 39, Issue 2, February 2003, Pages 179-189 Vittorio Gebbia, Domenico Galetta, Michele Caruso, Francesco Verderame, Giuseppe Pezzella, Matteo Valdesi, Nicolò Borsellino, Giuseppe Pandolfo, Ernesto Durini, Massimo Rinaldi, Michele Loizzi, Nicola Gebbia, Roberto Valenza, Maria Lina Tirrito, Francesca Varvara, Giuseppe Colucci Abstract Purpose: we carried out a phase III randomized trial to compare vinorelbine–cisplatin regimen to gemcitabine–cisplatin regimen, and to a sequential administration of gemcitabine–ifosfamide followed by vinorelbine–cisplatin or the opposite sequence of vinorelbine–cisplatin followed by ifosfamide–gemcitabine according to the ‘worst drug rule’ hypothesis in patients with locally advanced unresectable stage IIIB or metastatic stage IV non-small cell lung cancer. The primary endpoint was survival parameters, while secondary endpoints included analysis of response rates and toxicity. Patients and methods: patients were randomized to receive: (a) gemcitabine 1000 mg/m2 on days 1, 8 and 15 plus ifosfamide 1500 mg/m2 on days 8–12 with mesna uroprotection (GI regimen) followed by vinorelbine 25 mg/m2 on days 1 and 8 plus cisplatin 100 mg/m2 on day 1 (GI→VC regimen); (b) the opposite sequence (VC→GI); (c) vinorelbine plus cisplatin as above described (VC regimen); or (d) gemcitabine 1400 mg/m2 on days 1 and 8 plus cisplatin 100 mg/m2 on day 8 (GC regimen). All regimens were given every 4 weeks. All patients were chemotherapy naive and had a ECOG PS 0-2. Results: 400 patients were enrolled into the trial. Interim analysis after inclusion of 243 patients showed that ORR were 19%in the GI→VC arm, 32%in the inverse sequence arm (CV→GI), 42%in the VC arm, and 30%in the GC arm. The VC arm was statistically superior over the GI→VC arm (p=0.0074), but not over the other regimens. Median TTP was 3.1 months in the GI→VC arm versus 5.0 months in the VC→GI arm (p=0.014). For these reasons the GI→VC and VC→GI arm were closed since the ‘worst drug rule’ hypothesis was rejected. Accrual in the VC and GC arms continued up to 140 and 138 patients respectively. Final ORR were 44%for the VC regimen (4 CR), and 34%for the GC regimen (1 CR). This difference was statistically significant (p=0.032). OS was 9.0 and 8.2 months, respectively, with no statistically significant difference. The 1-year survival rate was 24 and 20%, respectively for VC and GC regimens. As expected the incidence of phlebitis was higher in the VC arm, while thrombocytopenia, flu-like syndrome and asthenia were more frequent in the GC arm. Conclusions: the results of this trial indicate that the combination of vinorelbine and cisplatin and that of gemcitabine and cisplatin are equivalent in terms of median TTP and OS, although the vinorelbine–cisplatin regimen is associated with a higher ORR. Both regimens may be considered as reference treatments for future studies. Moreover, our data reject the ‘worst drug rule’ hypothesis of sequential treatments in NSCCL at least with the combination used in this study. Purchase PDF (179 K) |
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doi:10.1016/j.lungcan.2007.11.006 
Hybrid (intravenous and oral) administration of vinorelbine plus cisplatinum followed by oral vinorelbine as first-line therapy of advanced non-small cell lung cancer: A phase II study
