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Joel B. Finkelstein |
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The combination of vinorelbine
and gemcitabine for treating stage IIIB/IV non-small cell lung
cancer may offer a good alternative to cisplatin therapy and its
"notorious GI side effects," based on a phase II trial of 40
patients.
Treatment
with vinorelbine (Navelbine) plus gemcitabine (Gemzar) yielded a
high overall response rate of 72.5 percent. Two patients experienced
a complete response and 27 had a partial response, according to the
study conducted by Yuh-Min Chen, M.D., Ph.D., of the Veterans
General Hospital in Taipei, Taiwan, and associates.
The
median duration of response was just over seven months in the 40
patients. Median survival was 11 months, and nearly half of the
patients were still alive after one year. The study was published in
the June issue of Chest.
The main toxicities of concern were
hematologic, with about 50 percent of the patients experiencing
severe leukopenia and neutropenia. Although the only
treatment-related death was due to neutropenic sepsis, three
patients experienced febrile neutropenia. Severe thrombocytopenia
was seen in 12.5 percent of the patients and anemia in 20 percent.
Other side effects included skin rashes and fatigue or flu-like
syndromes.
Nausea and vomiting were reported in a minority
of patients. However, the study's participants were given antiemetic
prophylaxis with dexamethasone and metoclopramide.
The
researchers noted that histology seemed to offer some predictive
value. Among patients with adenocarcinoma or unspecified cell type,
the response rate was close to 90 percent, while in patients with
squamous cell carcinoma the response rate was below 50 percent.
The treatment protocol consisted of six four-week cycles
with infusions of vinorelbine and gemcitabine given on days 1, 8 and
15. The majority of patients (31) required dose reductions due to
myelosuppression, severe fatigue or hepatotoxicity. In the end, the
average doses patients received were 15 mg/m2/week of vinorelbine
and 600 mg/m2/week of gemcitabine.
A Multicenter Phase II
Trial of Vinorelbine Plus Gemcitabine in Previously Untreated
Inoperable (Stage IIIB/IV) Non-small Cell Lung Cancer. Yuh-Min Chen,
M.D., Ph.D., F.C.C.P.; Kuang-Yao Yang, M.D.; Tsang-Wu Liu, M.D.;
Chun-Ming Tsai, M.D.; Jacqueline Ming-Liu, M.D.; and Jacqueline
Whang-Peng, M.D. Chest, Vol. 117, No. 6 (June 2000), pp.
1583-1589
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