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Taxotere (Docetaxel) Plus Gemzar (Gemcitabine) Doubles Anti-Tumor Effects In Relapsed Lung Cancer: Presented at ASCO

NEW ORLEANS, LA -- May 23, 2000 -- The combination of weekly gemcitabine (GemzarŽ) and monthly docetaxel (TaxotereŽ) is active and safe in patients with advanced non-small-cell lung cancer (NSCLC) who have failed prior chemotherapy, according to the results of a phase II trial reported at the 36th Annual Meeting of the American Society of Clinical Oncology (ASCO). In addition, durable responses were observed at all disease sites and in cancers refractory to prior platinum therapy.
Twelve of 40 patients had a partial response to treatment, and one had a complete response, for an overall confirmed response rate of 32.5 percent. A partial response is defined as a 50 percent or greater decrease in measurable tumor size, while a complete response refers to a total disappearance of clinical and radiological signs of disease. The overall response rate is the sum of the complete and partial response rates. Half of the responses lasted longer than nine months and two of the responding patients remained in remission for more than a year. With the exception of tiredness, this drug combination was well tolerated.
"Despite the availability of new treatments for advanced non-small-cell lung cancer, most patients will eventually relapse and die of this disease," said C. Harris Spiridonidis, MD, Chairman of the Clinical Research Committee at the Columbus Community Clinical Oncology Program in Columbus, Ohio. "Putting together the two drugs gemcitabine and docetaxel essentially doubled the anti-tumor effects previously reported with each drug alone, resulting in one of the highest response rates ever seen in this group of relapsed lung cancer patients. The observation of long-lasting tumor shrinkage even in cancers that were growing larger during previous chemotherapy gives hope to people who until now have had extremely limited therapeutic options."
The study was undertaken because of earlier research showing that gemcitabine and docetaxel can be safely given together in patients with relapsed cancers, Dr. Spiridonidis explained. His group thus believed that the combination of gemcitabine with docetaxel in relapsed and refractory patients with NSCLC would result in a higher response rate and more durable responses than either drug used alone.
The trial enrolled 40 patients with biopsy-proven locally advanced or metastatic NSCLC who previously had been treated with a single chemotherapy regimen, excluding gemcitabine or taxanes, in the adjuvant, locally advanced, or metastatic setting. All patients had at least one measurable lesion and a SWOG (Southwest Oncology Group) performance status of zero to two. Twenty-nine patients were men, and 11 were women; their median age was 62 years. Thirty-six patients had received prior platinum-based chemotherapy, combined with either vinorelbine (NavelbineŽ) or VP-16 (EtoposideŽ), and four patients had received prior single-agent therapy without platinum.
Patient characteristics of prior (first-line) chemotherapy were as follows: 14 patients were refractory to prior therapy, meaning their tumors had grown in size while receiving first-line chemotherapy; Eighteen patients had treatment-resistant disease, meaning no tumor shrinkage during initial therapy, or tumor coming back within three months of completing initial therapy; Six patients had treatment-sensitive tumors, meaning that they initially responded, but then their tumors came back more than three months after treatment completion.
All subjects received gemcitabine, 800 mg/m(2), administered intravenously over 30 minutes on days one, eight and 15 every four weeks, plus docetaxel, 100 mg/m(2), administered intravenously over one hour on day one after gemcitabine, also every four weeks. Responses were assessed after the second cycle of chemotherapy and confirmed after the fourth cycle.
All patients were evaluable for treatment response. Responses occurred in four of the 14 treatment-refractory patients, six of the 18 treatment-resistant patients, and two of six treatment-sensitive patients. The metastatic sites that responded to treatment included the lung, lymph nodes, bones, brain, liver, adrenal, skin and renal.
The median survival was eight months, and 32 percent of patients were projected to be alive beyond one year. Moderate or severe side effects included asthenia (weakness) in 13 patients and edema (fluid retention) in four patients. Mucositis (inflammation of a mucous membrane), flu-like diarrhea, neuropathy (a functional disturbance and/or pathological change in the peripheral nervous system), and increased liver enzymes occurred in one patient each. Severe neutropenia (low white blood count) occurred in 58 percent of patients but it was complicated by fever in only four patients.
Lung cancer is the second leading cause of cancer-related deaths worldwide and is largely due to tobacco use. While the incidence of lung cancer in men has leveled off, the incidence in women continues to increase. Among women, lung cancer now surpasses breast cancer as the leading cause of cancer-related death. The great majority (80 percent) of lung cancers belong to the non-small-cell lung cancer category and most present with advanced disease, treated primarily with chemotherapy or chemotherapy plus radiation. Despite recent progress, only 25 percent of patients with metastatic disease respond to first-line chemotherapy and these responses are generally short-lived.
The Columbus Community Clinical Oncology Program (Columbus CCOP) is a non-profit cancer research program funded by The National Cancer Institute. Originating in 1983 at a local hospital with only a handful of oncology-related professionals, The Columbus CCOP has evolved into a consortium of 13 Central Ohio hospitals with over 100 member physicians. Their purpose is to bring state-of-the-art cancer treatment and prevention strategies to local physicians and the patients they serve. This allows individuals to remain in their own communities while receiving the latest and best in cancer screenings, diagnostic care and treatment plans.
Related Links: gemcitabine (Gemzar) and docetaxel (Taxotere).

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