American Society of Clinical Oncology: Chemotherapy and Radiation Therapy in Glioblastoma Multiforme
Speaker: Roger Stupp, MD, Professor of Medicine and Director, Brain Tumor and Chest Oncology Clinic, Multi-disciplinary Oncology Center, University of Lausanne Hospital, Vaudois, Lausanne, Switzerland.
The addition of temozolomide (Temodar®, Schering), a chemotherapeutic agent indicated for the treatment of ana-plastic astrocytoma, to standard radiation therapy significantly improved both progression-free survival and overall survival in patients with glioblastoma multiforme, a fast-growing primary brain tumor that is difficult to treat.
A randomized phase III clinical trial was conducted in more than 80 institutions throughout Europe, Canada, and Australia. A total of 573 new patients with histologically proven disease were enrolled in the study; 286 patients were randomly assigned to standard radiation therapy of 60 gray (Gy) in 30 daily fractions of 2 Gy; 287 patients received the same radiation therapy and concomitant oral temozolomide 75 mg/m2 daily for up to 42 days, followed by up to six cycles of adjuvant oral temozolomide 150 to 200 mg/m2, daily for five days every 28 days. The primary endpoint was survival, with the aim of a 30% improvement. cheap cialis canadian pharmacy
At two years’ follow-up, the median survival time was 15 months for patients treated with both temozolomide and radiation and 12 months for patients who received radiation therapy alone. Progression-free survival was 7.2 months in the chemotherapy-plus-radiation patients but five months in the radiation-only patients.
Both parameters improved significantly in patients receiving temozolomide plus radiation. It is noteworthy that the addition of chemotherapy to radiation therapy more than doubled the chances that patients with gliobastoma multiforme would be alive for two years, in contrast to patients treated only with radiation therapy: 27% of patients receiving temozolo-mide plus radiation therapy and 10% of those receiving radiation therapy alone survived two years.
One key to the effectiveness of this new therapy is that temozolomide caused few side effects and it was well tolerated. Patients can take the drug every day during radiation treatment instead of once every eight weeks, the common dosing schedule for other chemotherapeutic agents.
Anti-Epidermal Growth Factor Human Monoclonal Antibody in Advanced Non-Small Cell Lung Cancer
Speaker: Jeffrey Crawford, MD, Professor of Medicine, Interim Director of Medical Oncology, and Director of Clinical Research, Duke Comprehensive Cancer Center, Duke University Medical Center, Durham, North Carolina.
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In an interim analysis of a two-part phase II study, front-line therapy with panitumumab (Amgen/Abgenix), a fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFr), was well tolerated when given with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer (NSCLC). Results demonstrated encouraging response rates and enhanced survival outcomes in the small number of patients in the dose-finding part of this study.
In this first part of the study, 19 patients were enrolled into three groups. Six patients received panitumumab 1.0 mg/kg, seven patients received 2.0 mg/kg, and six patients received 2.5 mg weekly. The drug was administered for up to eight six-week cycles. Patients also received intravenous (IV) paclitaxel 200 mg/m2 over three hours every three weeks and carbo-platin to target the area under the curve (AUC) of 6 for up to six three-week cycles. Responses were evaluated at the end of the sixth week of each panitumumab cycle, and results were confirmed at least three weeks later or more.
Five of the 19 patients had objective responses, with one complete response and four partial responses; 12 patients experienced stabilization of disease; and two patients experienced disease progression. The observed duration of response to date was six months, and the median overall survival was 17 months, a notably greater survival than with chemotherapy alone in patients with advanced NSCLC.
As noted, panitumumab at all three doses was safe in combination with paclitaxel and carboplatin. The most common ADE observed was skin rash, but the incidence of grade 3 rash did not increase with the dose.
Part 2 of this study is designed to confirm these findings and to compare the time to progression with panitumumab plus chemotherapy versus chemotherapy alone as front-line therapy for patients with advanced NSCLC. Enrollment has been completed, and at the time of this writing, 175 patients were receiving treatment.
New Chemotherapeutic Combination for Advanced Pancreatic Cancer
Speaker: Christophe Louvet, MD, Professor of Medicine and Deputy Director, Oncology Department, Saint Antoine Hospital and University, Paris, France.
The combination of gemcitabine (Gem) (Gemzar®, Eli Lilly) and oxaliplatin (Ox) (Eloxatin™, Sanofi-Synthelabo) significantly improves the treatment outcomes of advanced pancreatic cancer, compared with gemcitabine alone, particularly in response rates, clinical benefits, and progression-free survival.
A French and Italian intergroup, phase III clinical trial compared the efficacy and safety of gemcitabine and oxaliplatin with standard treatment consisting of gemcitabine alone in patients with nonresectable locally advanced. A total of 313 patients were randomly assigned to receive gemcitabine 1 g/m2 in a two-hour IV infusion on the second day (GemOx) every two weeks or gem-citabine alone 1 g/m2 in a 30-minute IV infusion weekly.
A final analysis of the data confirmed significantly improved overall response rates with the GemOx combination (28.7%) compared with gemcitabine alone (16.7%). Median progression-free survival was 5.5 months with GemOx and 3.7 months with gemcitabine. The clinical benefit response rates were 38.9% in the GemOx group and 29.2% in the gemcitabine-alone group, with both parameters significantly improved in the GemOx arm of the study.
Overall survival, although not statistically significant, was better than had been expected in both arms of the study: 7.1 months for the gemcitabine patients and 9.0 months for the GemOx patients. The projected survival for each arm had been six and eight months, respectively.
Tags: Clinical Oncology, Colon Cancer, Drug Combination, Glioblastoma Multiforme