Effect of oral pilocarpine on post-irradiation xerostomia in head and neck cancer patients: a single-center, single-blind clinical trial.

OBJECTIVE: The authors determined the efficacy and safety of oral pilocarpine tablet in symptomatic relief of post-radiation xerostomia in head and neck cancer patients. MATERIAL AND METHOD: Thirty-three radiation-induced xerostomia patients were enrolled in a single-blind method to receive placebo 1-tablet three times daily in the first month and then oral pilocarpine (5 mg) 1-tablet three times daily for the next three months. Patients were evaluated for subjective symptomatic relief of xerostomia using questionnaires. Objective findings of xerostomia were also evaluated at the same time by two radiation oncologists. RESULTS: All 33 patients had received radiotherapy doses at least 4000 cGy to the parotid glands. Improvement of xerostomia symptoms was observed, with a mean total subjective xerostomia score improvement at the first 4 weeks of oral pilocarpine treatment (p = 0.001), and later throughout the present study. Objective xerostomia score also showed statistically significant improvement at the same time point. Adverse effects of pilocarpine included sweating, nausea, palpitation, and tearing, with sweating as the most common side effect. Adverse effects of placebo included mild headache, nausea, and vomiting. CONCLUSION: Oral pilocarpine was effective and well tolerated in the treatment of radiation-induced xerostomia symptoms.

FOLFIRI chemotherapy for metastatic colorectal cancer patients.

OBJECTIVES: 1) To confirm the efficacy of irinotecan plus folinic acid/continuous 5-fluorouracil as bimonthly FOLFIRI regimen in metastatic colorectal cancer patients. Efficacy evaluations will include response rate, duration of response, and survival. 2) To evaluate safety profiles on patients receiving this combination. MATERIAL AND METHOD: Nineteen patients with metastatic colorectal cancer received 180 mg/m2 intravenous (iv) day 1 of irinotecan, 200 mg/m2 iv of folinic acid, 400 mg/m2 iv bolus days 1 to 2, 5-fluorouracil (5-FU), and 600 mg/m2 iv 5-FU infusion over 22 hours, days 1 to 2. Treatment was repeated every two weeks and one cycle contained three fortnightly administrations. Sites of disease were liver in nine patients, lungs in three patients, bowels in four patients, lymph nodes in three patients, and peritoneum in two patients. Two patients had > 1 metastatic site. Previous treatments included adjuvant chemotherapy in seven cases and front-line chemotherapy for advanced disease in one case. RESULTS: A median of six treatment cycles was completed (range, 2-13 cycles). All patients were assessable for toxicity and 16 patients were evaluable for treatment response. The non-hematological toxicity was mild. Most had grade 1 or 2. Only one patient experienced grade 3 fatigue and anorexia, and discontinued chemotherapy after the second cycle. There were no cases with grade 4 toxicity. Fourteen patients had at least grade 2 alopecia. The most common hematological toxicity was neutropenia. Grade 3 and 4 neutropenia were observed in three and two patients, respectively. There was no case of febrile neutropenia. Based on intention to treat analysis, there were no complete responses (CR), five (26.3%) partial response (PR), and 11 (57.9%) stable disease. With the median follow-up of 6.6 months, the median time to disease progression was 4.7 months and the median survival time was 10.6 months. CONCLUSION: Bimonthly irinotecan in combination with folinic acid and 5-fluorouracil was active with acceptable toxicities and a prolonged survival time in pretreated colorectal cancer. Additional trials to define the optimal dose and schedule of treatment are justified.

Radiotherapy in Kimura's disease: a report of eight cases.

Kimura's disease is a rare condition of chronic inflammatory disorder affecting the skin and subcutaneous tissue. It is predominantly in the head and neck region. The lesion is benign but may be persistent/ recurrent and difficult to eradicate. Several forms of treatment have been used, including surgical excision, intralesional and oral corticosteroid, cryotherapy and radiotherapy. The authors report eight cases with histopathology consistent with Kimura s disease who received radiation therapy as a primary treatment or secondary treatment for recurrence after surgical excision in the Division of Therapeutic Radiology and Oncology, Chiang Mai University. The prescribed radiation doses varied from 30-40 Gy. With the mean follow-up time of 21 months, all eight patients were still free from disease at the time of analysis.

Effect of Amifostine to prevent radiotherapy-induced acute and late toxicity in head and neck cancer patients who had normal or mild impaired salivary gland function.

BACKGROUND: Amifostine has a potential role for salivary gland protection in head and neck cancer patients who had radiotherapy. MATERIAL AND METHOD: Sixty-seven head and neck cancer patients were randomized to receive radiotherapy or radiotherapy plus Amifostine. The efficacy of the treatment was determined by a questionnaire evaluating dryness of mouth and the oral comfort, the RTOG/EORTC acute/late radiation morbidity scoring criteria, collection of the whole saliva and the 99mTc-pertecnetate scintigraphy of the salivary glands. RESULTS: Amifostine significantly reduced the mean questionnaire scores from 6.49 to 3.73, the incidence of grade > or = 2 mucositis from 75% to 36% and acute xerostomia from 82% to 39%. The salivary gland function returned to normal at a rate of 36.3% in the Amifostine group versus 9.1% in the control group. CONCLUSION: Amifostine is effective in reducing the incidence and severity of acute mucositis, acute and late xerostomia in head and neck cancer patients.

Preoperative capecitabine with pelvic radiotherapy for locally advanced rectal cancer (phase I trial).

OBJECTIVE: Phase I multicenter study defined the maximal tolerated dose (MTD), dose-limiting toxicity (DLT) and safety profile of capecitabine in combination with preoperative radiation for patients with locally advanced rectal cancer (LARC). MATERIAL AND METHOD: Patients were treated with oral capecitabine (700, 800, 900, 1000, 1100 and 1200 mg/m2 twice daily continuously) plus preoperative whole pelvic irradiation (45-46 Gy in 23-25 fractions over 5-6 weeks). Surgery was performed at the median of 42 days after chemoradiation treatment. RESULTS: Twenty-seven patients were in this trial. Eighteen patients (3 per dose level) had received capecitabine from 700 mg/m2 twice daily to the highest dose level of 1200 mg/m2 twice daily. There were no grade 3/4 DLTs during dose escalation, a further nine patients were included at the highest capecitabine dose. Two of the twelve patients (16%) receiving capecitabine 1200 mg/m2 twice daily developed grade 3 diarrhea and discontinued treatment. There were no other grade 3/4 adverse events. After capecitabine chemoradiation, 24 of 27 patients (89%) received definite surgery. Primary and lymph node down staging occurred in ten patients (42%). Sphincter-sparing surgery was performed in seven patients (26%) and abdominal-perineal resection was performed in 17 patients (63%). CONCLUSION: Preoperative capecitabine chemoradiation based on continuous daily capecitabine is very well tolerated in patients with LARC. The authors did not reach the MTD in the present study.

Evaluation of safety and efficacy of transdermal therapeutic system-fentanyl in adult patients with gynecological cancer-related pain.

OBJECTIVES: To assess the analgesic safety and efficacy of Transdermal Therapeutic System (TTS)-fentanyl in the treatment of chronic gynecological cancer-related pain. BACKGROUND: TTS-fentanyl is a Transdermal Therapeutic System, which contains a rate-limiting membrane that provides constant release of fentanyl. TTS-fentanyl can be properly used to control pain. Therefore, this trial was designed to establish the analgesic efficacy and safety of TTS-fentanyl in the treatment of chronic gynecological cancer-related pain. MATERIAL AND METHOD: Thirty patients were recruited into the study. This open study was comprised of two phases. Phase 1: an oral morphine stabilization phase where eligible patients, who took other opioids and/or analgesic drugs, were entered into the stabilization phase and should be converted to oral morphine according to the conversion chart. The patients were then titrated to a stable oral morphine dose. Phase 2: an open TTS-fentanyl treatment phase where the daily dose of oral morphine was switched to TTS-fentanyl according to the conversion chart. The efficacy parameters of pain score were assessed by visual analogue scale (VAS) and global assessments. The safety was evaluated by monitoring the patient's clinical conditions and adverse events. RESULTS: TTS-fentanyl was generally well tolerated. Only one patient was dropped out from the study due to lacking enrollment in the stabilization phase. The most frequent adverse events were mild nausea or vomiting (46%) and constipation (33%). The median pain VAS during TTS-fentanyl treatment was decreased from 8 to 3 and global assessments at the end of the treatment were better than at the start of the treatment. CONCLUSION: The results suggest that TTS-fentanyl is safe and effective in managing chronic gynecological cancer-related pain.