phase II study of gemcitabine concurrent with radiation in locally advanced squamous cell carcinoma of head and neck: a trial of the cancer research group Pakistan

To evaluate the efficacy and toxicity of weekly gemcitabine as a radiosensitizer concurrent with radical radiotherapy in locally advanced carcinoma of head and neck. From August 2001 to January 2002, thirty-nine patients with stage III or IV B inoperable carcinoma of head and neck were enrolled. Patients with histopathologically confirmed squamous cell carcinoma with at least one bidimensionally measurable lesion, no prior chemotherapy or radiotherapy, and a KPS of 60 or above were included. Patients with nasopharyngeal, glottic or sub-glottic cancer were excluded. Gemcitabine 150mg/m2 or a total dose not exceeding 200 mg was given on day 1, 8, 15, 22, 29, and 36 during radiation treatment. Radiation was delivered with conventional fractionation to a total dose of 66-70Gy. Miller's criteria was used for response evaluation. RTOG/EORTC acute radiation [and chemotherapy] morbidity scoring system and WHO grading of acute and sub acute toxicity criteria were used for documentation of toxicity. All 39 patients were evaluable for toxicity but only 35 patients were evaluable for response. An overall response rate of 94.3% [95% CI; 80.8-99.3] was seen with a partial response rate of 71.4% and complete response rate of 22.9% [95%CI; 10.4-40.1]. Grade 3 mucositis was seen in 28 patients [71.8%]. Grade 4 mucositis was seen in 2 patients [5.1%]. Pharyngeal toxicity was the second-most common toxicity. Grade 2 toxicity was seen in 12 patients [30.8%] and grade 3 in 6 patients [15.4%]. Despite vigorous symptomatic and supportive care acute toxicities led to treatment interruption in 40% of patients. A high overall response rate and a high rate of acute toxicity are seen at a weekly gemcitabine dose of 150mg/m2 concurrent with radiation. This shows that gemcitabine is a potent radiosensitizer with a marked tumor and normal tissue radio sensitization

Toxicity profile and objective response of paclitaxel in metastatic breast cancer

To evaluate the efficacy and toxicity of 1-hour weekly Paclitaxel in metastatic breast cancer along with evaluation of overall survival. A phase II interventional trial. Oncology Department, Combined Military Hospital, Rawalpindi, between August 2001 to July 2003. Thirtysix patients were enrolled in the study. All patients with histologically confirmed and bidimensionally 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. 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. 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

To evaluate the clinical benefit and tolerability of letrozole after tamoxifen failure in locally advanced, recurrent or metastatic breast cancer in postmenopausal patients. A phase II non-randomized trial Oncology Department, Combined Military Hospital, Rawalpindi, from March 1999 to February 2001 over a period of 2 years. 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. 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. 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