Gefitinib induction followed by chemoradiotherapy in EGFR-mutant, locally advanced non-small-cell lung cancer: LOGIK0902/OLCSG0905 phase II study.

BACKGROUND: The role of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) induction coupled with standard concurrent chemoradiotherapy (CRT) is unclear in unresectable, stage III, EGFR-mutant non-small-cell lung cancer (NSCLC). Therefore, a phase II trial was conducted to evaluate the efficacy and safety of gefitinib induction followed by CRT in this disease setting. PATIENTS AND METHODS: Patients with unresectable, EGFR-mutant, stage III NSCLC were administered gefitinib monotherapy (250 mg/day) for 8 weeks. Subsequently, patients without disease progression during induction therapy were administered cisplatin and docetaxel (40 mg/m2 each) on days 1, 8, 29, and 36 with concurrent radiotherapy at a total dose of 60 Gy. The primary endpoint was the 2-year overall survival (OS) rate, which was hypothesized to reach 85%, with a threshold of the lower limit of 60%. RESULTS: Twenty patients (median age: 66 years; male/female: 9/11; histology: 20 adenocarcinoma; stage IIIA/IIIB: 9/11; and exon 19/21: 10/10) were enrolled. The 2-year OS rate was 90% (90% confidence interval: 71.4% to 96.8%), indicating that this trial met the primary objective. The overall response rate and 1- and 2-year progression-free survival rates were 85.0%, 58.1%, and 36.9%, respectively. Grade ≥3 adverse events (>10%) included hepatic toxicity during the induction phase and neutropenia and febrile neutropenia in the CRT phase. Radiation pneumonitis grade ≥3 or treatment-related death did not occur. CONCLUSIONS: This is the first prospective study to demonstrate the favorable efficacy and safety of EGFR-TKI induction followed by standard CRT in EGFR-mutant, stage III NSCLC. Further confirmatory studies are needed.

Radiotherapy with concurrent docetaxel and carboplatin for head and neck cancer.

BACKGROUND: This study was designed to evaluate the concomitant use of docetaxel and carboplatin for radiosensitization in head and neck cancer. MATERIALS AND METHODS: One dose of docetaxel at 10 mg/m2 and five doses of carboplatin at AUC of 0.4 per week were administered to patients during the first two weeks of radiotherapy. Sixteen patients were treated with this regimen. Radiotherapy was given to a total dose of 64.8 to 82.0 Gy. Altered fractionation radiotherapy was performed in 12 patients with untreated advanced tumors. RESULTS: The complete response (CR) rate was 81%, with a partial response (PR) rate of 19%. Toxicities included grade 3 mucositis in 69% of patients and grade 2 dermatitis in 56% of patients. CONCLUSION: This schedule of docetaxel and carboplatin combined with radiotherapy may become a useful approach for the management of head and neck cancer with proper management of mucositis.

[Radiotherapy for outpatients].

Radiotherapy can be done on an outpatient basis depending on the patient's cancer stage, radiation method, concurrent therapy, treatment purpose and general condition. Daily treatment time takes only about 1 minute, but the patient has to come 5 times a week for about 6 weeks for radical treatment and about 3 weeks for palliative treatment. If treated with radiotherapy alone, most patients suffer no severe adverse effects in their daily life. Therefore, radiotherapy can be done on an outpatient basis only if the patient is able to come frequently to the clinic for several weeks. Breast cancer patients commonly undergo radiotherapy in the outpatient clinic, such as breast conserving therapy, postoperative therapy and radiotherapy for local recurrence after mastectomy. Prostate cancer is also commonly treated with radical radiotherapy, postoperative therapy and radiotherapy for local recurrence after prostatectomy. Usually, postoperative irradiation for other cancers and radiotherapy for bone metastases are also undergone on an outpatient basis. During outpatient treatment, it is important to predict and avoid severe normal tissue reactions to radiotherapy, such as myelosuppression and/or pneumonitis, before they are apparent by watching the patient carefully.

[Effectiveness of 3 ways method in intra-arterial infusion chemotherapy for advanced or recurrent cervical cancer with or without radiotherapy].

We analyzed 58 cases of advanced or recurrent cervical cancer treated with intra-arterial infusion chemotherapy (IAIC) with or without radiotherapy. Two separate IAIC regimens were administered since 1985: group I consisted of 5-FU + MMC +/- ADR (30 patients) and group II consisted of CDDP + MMC +/- 5-FU (28 patients). The tip of a catheter was placed in the bifurcation of the abdominal aorta (1 way method: 45 patients regimen II: 15) between 1977-1984. We have used selective catheterization (2 ways method: 9) since 1995 in order to get good drug distribution. However we experienced grade 4 toxic effect of cutaneous and pain with this method, so we have used a 3 ways method (4 patients) since 1998. The two-year survival rete was 60% with the 1 way method, and 67% with the 2 ways method and regimen II. Severe adverse effects (grade 3 + 4) were found in 53, 56, 0%, respectively, by each of the three methods (1, 2, 3 ways) hematologically, 13, 22, 0% in gastrointestinally, 0, 44, 0% in cutaneously and 0, 56, 0% in pain or neurotoxicity. These data suggest that IAIC by the 3 ways method is a useful treatment for advanced or recurrent cervical cancer. However, one should check the blood flow distribution periodically, and control concentration of drugs.