Toxicity profile and objective response of paclitaxel in metastatic breast cancer.

OBJECTIVE: To evaluate the efficacy and toxicity of 1-hour weekly Paclitaxel in metastatic breast cancer along with evaluation of overall survival. DESIGN: A phase II interventional trial. PLACE AND DURATION OF STUDY: Oncology Department, Combined Military Hospital, Rawalpindi, between August 2001 to July 2003. PATIENTS AND METHODS: Thirty-six patients were enrolled in the study. All patients with histologically confirmed and bi-dimensionally measurable metastatic breast cancer who had received previously either chemotherapy or hormone therapy were included in the study. Paclitaxel was administered in 1-hour weekly infusion in a dose of 100 mg/m2 for 12 doses. RESULTS: All patients had received previous chemotherapy with either CAF or CMF. Twenty-five patients had also received hormone therapy, 61% had two or more metastatic sites involved, and lung was the common site of involvement. Complete response was observed in 4 (11.1%) patients, partial response in 14 (38.8%) patients, with an overall response rate of 50.0%. Clinical benefit was 94.4% and median overall survival was 11 months. Treatment was well-tolerated with no grade 3 or 4 toxicity. Common side effects were arthralgias, myalgias and neutropenia. CONCLUSION: Treatment with 1-hour weekly infusion of Paclitaxel is a well-tolerated chemotherapy with a substantial degree of efficacy in patients with metastatic breast cancer.

Efficacy of letrozole for advanced breast cancer in postmenopausal patients.

OBJECTIVE: To evaluate the clinical benefit and tolerability of letrozole after tamoxifen failure in locally advanced, recurrent or metastatic breast cancer in postmenopausal patients. DESIGN: A phase II non-randomized trial. PLACE AND DURATION OF STUDY: Oncology Department, Combined Military Hospital, Rawalpindi, from March 1999 to February 2001 over a period of 2 years. PATIENTS AND METHODS: One hundred and seventeen patients with tamoxifen failure were treated with letrozole 2.5 mg once daily, through oral route. All the accrued patients were either estrogen/progesterone receptor positive or unknown with KPS of more than 50%. Patients who had prior hormone therapy other than tamoxifen, or more than one chemotherapy for recurrent or advanced disease were not enrolled in the study. Time to progression (TTP) was the primary objective, whereas objective response (OR), duration and rate of clinical benefit (complete response + partial response + stable disease >6 months), tolerability and effects on quality of life were the secondary end points. RESULTS: The clinical benefit was 47.0% with an objective response of 28.2%. The objective response and median time to progression in soft tissue disease was better than in the visceral and bone disease. The median time to progression for patients having positive estrogen receptor / progesterone receptors (ER / PR) was 9.5 months which is slightly higher than in patients having unknown ER / PR status. The treatment with letrozole was well-tolerated with side effects observed in only 14 patients. CONCLUSION: Letrozole is an effective hormone therapy after tamoxifen failure since it has significant clinical benefit and objective response. It can be safely used as second line hormone therapy in postmenopausal patients with locally advanced or metastatic breast cancer.

Management of oromandibular cancers.

OBJECTIVE: To emphasize the role and importance of multidisciplinary approach in the management of oral cavity cancers involving the mandible. DESIGN: Descriptive study. PLACE AND DURATION OF STUDY: The Departments of Plastic and Reconstructive Surgery, ENT / Head and Neck Surgery and Radiation Oncology, Combined Military Hospital, Rawalpindi. Duration spans over a period of six years. SUBJECTS AND METHODS: A total of 63 patients who had biopsy-proven oromandibular tumors, after thorough assessment / staging in Joint Head and Neck Oncology Clinic, underwent resection and reconstruction for malignant oral cavity tumors involving the mandible were included in the study. All the resected tumor specimen were sent for histopathology. All the post-resection defects were properly classified and reconstructed by the plastic surgery team. Postoperatively, all the patients underwent adjuvant full dose radiotherapy at the Department of Radiation Oncology. Complications were recorded and managed accordingly. At one year follow-up all the available patients were assessed for functional and aesthetic restoration and recurrences. RESULTS: Out of 63 patients there were 40 males and 23 females (ratio 1.7 : 1) with an average age of 50 years. Tumor-free resection margins could be achieved in 56 patients. In 88% cases tumor was a Squamous cell carcinoma. Radical neck dissections were carried on in 27 patients. Radial forearm free flap was used in 27 patients, pectoralis major myocutaneous flap in 19, free fibula osteocutaneous flap in 10, rectus-abdominis myocutaneous free flap with Implant was used in 3 patients to reconstruct the post-resection defects. There was only one total flap loss and 3 partial flap losses. Implant exposure was encountered in 4 instances with 3 major and 5 minor fistulae. At one year follow-up, 56 patients were available. Thirty-seven patients had intelligible speech, 15 patients were taking normal diet and in 33 patients there was a satisfactory mandibular contour restoration. Seven patients had recurrences, 2 were not traceable and 5 patients had died by that time. CONCLUSION: A multidisciplinary collaboration is the key to effectively manage this group of extremely debilitating malignancies.