Lung Cancer Study Demonstrates Potential Utility Of Taxotere(R)/Carboplatin Combination

Athens, Greece (ots-PRNewswire) - The following was released by Martin Luther University:

Combination treatment with the anticancer agents Taxotere(R)(docetaxel) for Injection Concentrate and carboplatin is a potentially useful therapy for advanced non-small-cell lung cancer (NSCLC), according to results reported at the 23rd Congress of the European Society for Medical Oncology (ESMO).

To date, patients with metastatic NSCLC have relatively limited treatment options. Twenty-five percent of all patients have localized disease and are candidates for a complete resection (surgical removal of the tumor). The modest antitumor activity and clinical benefit of standard platinum-containing multidrug regimens has prompted a search for novel combinations. For example, standard treatment using platinum based combinations has yielded modestly superior median survival time (7 months vs. 4 months for best supportive care).

The new data, drawn from a Phase II trial, show response to therapy that combines Taxotere with the platinum compound carboplatin in patients with stage IIIb-IV inoperable NSCLC. Taxotere is not approved in the U.S. for NSCLC.

"We are particularly encouraged by our survival data," said Dr. Wolfgang Schutte, Head of the Department of Internal Medicine at the City Hospital Martha-Maria, Halle-Dolau, Germany, and principal investigator of the study.

The Study

The trial included 30 chemotherapy-naive patients with histologically confirmed measurable disease, a World Health Organization Performance Status of 0-2 without brain metastases, and adequate hematologic, hepatic, and renal function. Twenty-three patients had stage IV disease, and seven had stage IIIb disease.

Patients received Taxotere, 90 mg/m2, as a one-hour infusion on day one, followed by standard carboplatin dosing-(dosed to a targeted area under the concentration vs. time curve of 5). Treatment was repeated every three weeks for six cycles.

The Results

Two (6.6 percent) of 30 patients enrolled in the study had a complete response, or a complete disappearance of all clinical and radiological signs of cancer. Seven (23 percent) patients had a partial response, which refers to a 50 percent or greater decrease in measurable tumor size. Stable disease was documented in 14 (46 percent) patients, while the disease progressed in seven (23 percent) patients. The median survival was 57 weeks, and the one- year survival was 56 percent.

According to Dr. Schutte, the side effects observed in the study were predictable. Grade 3 or 4 granulocytopenia (a decrease in granulocyte white blood cells) occurred in 23 (76 percent) patients without any infections or febrile neutropenia (a decrease in neutrophil white blood cells accompanied by fever). Non-hematologic toxicity, mainly grade 1-2, occurred in 14 (46 percent) patients with nail alterations and mild edema.

"Prophylactic use of G-CSF was not necessary and the therapy was well tolerated," Dr. Schutte said.

Lung Cancer

Lung cancer is the leading cause of cancer-related deaths worldwide. Non-small-cell types of lung cancers account for 75 percent of all lung cancer cases. The World Health Organization (WHO) estimates that almost one million persons die from lung cancer and more than 1.3 million new cases are diagnosed every year. The American Cancer Society reports that over the last decade, more women have died each year from lung cancer than breast cancer- an estimated 160,000 deaths are projected in 1998.

ots Original Text Service: Martin Luther University,

Dr. W. Schutte, Martin Luther University
Department of Internal Medicine II
at the City Hospital Martha-Maria
06120 Halle-Dolau
Tel: (Germany) +03 45 5 59 14 40