A multicentre randomized/controlled trial of a conventional versus modestly accelerated radiotherapy in the laryngeal cancer: influence of a 1 week shortening overall time.

BACKGROUND AND PURPOSE: To compare in a phase III study the loco-regional control, disease-free survival and overall survival induced by an accelerated regimen (AF) as compared with conventional regimen (CF) and to analyze the early and late post-radiation morbidity in both arms. MATERIALS AND METHODS: Patients with age < or = 75, WHO 0-1, suitable for a radical course of radiotherapy T1-T3, N0, M0, stage of glottic and supraglottic laryngeal cancer were randomized to either CF: 66Gy given in 33 fractions over 45 days or AF: 66Gy given in 33 fractions over 38 days (2 fractions every Thursday). A total of 395 patients were included from 05.1995 to 12.1998. RESULTS: Early toxicity: At the end of radiotherapy patients treated with AF complained for more severe reactions than patients treated with CF. In 8 weeks after treatment completion patients treated with AF complained only for more severe pain on swallowing (P=0.027). In 4 months after treatment completion all types of toxicity except for skin teleangiectasia (P=0.001) were similar in the two groups. Loco-regional control: comparison between CF and AF showed no difference in terms of loco-regional control (P=0.37). CONCLUSIONS: The improvement in AF in terms of loco-regional control is estimated to be 3-5% in comparison with conventional regimen and is not significant. The intensity of reactions after 4 months was similar in both arms, what suggests the possibility of further shortening of the overall time by few days or enhancing the total dose within the limits of acceptable morbidity.

[Results of palliative treatment of advanced regional oropharyngeal cancer]. / Wyniki paliatywnej radioterapii miejscowo zaawansowanego raka plaskonablonkowego ustnej czesci gardla.

We present results of palliative radiotherapy in 76 oropharyngeal advanced cancer patients. We recommend, according to appreciated results of palliative treatment, the two high fractionation dose courses (so called split course) if the first application of high fractionation dose had resulted in partial remission. Conventional fractionation dose in the second part of split course of radiotherapy did not result in better effect in regression, better subjective feeling after radiotherapy and longer survival time in our material. Patients with poor presentation status (Zubrod 3) should be excluded from palliative radiotherapy.

[Concomitant radiochemotherapy for locally advanced oro- and hypopharyngeal cancer: tolerance and early results]. / Jednoczesna radiochemioterapia u chorych na raka gardla srodkowego i dolnego: tolerancja i wczesne wyniki leczenia.

Combination of radio- and chemotherapy is one of the methods which may improve results of treatment in patients with locally advanced head and neck cancer. Currently, the most promising sequence of radio- and chemotherapy is concomitant. In Head and Neck Cancer Department of Cancer Center in Warsaw since 1995 is continued study estimated tolerance and effectiveness of the concomitant radiochemotherapy for patients with locally advanced oro- and hypopharyngeal cancer. Chemotherapy consist of cisplatinum and 5-fluorouracil in continuous infusion during first week of irradiation followed by 24-hours infusion of 5-fluorouracil one weekly until radiotherapy is finished. Radiotherapy is used with conventional fractionation 2 Gy per fraction, 5 fractions weekly to total dose 66 Gy. Between October 1995 and September 1998 fifty seven patients with oropharyngeal cancer were entered to study. Tolerance of treatment was acceptable. Complete regression of the tumor was obtained in 41/57 patients (72%). Five other patients after radiotherapy were referred for successful radical neck dissection. Including this group, local control was obtained in 81%. At this moment, 60% of patients are alive without evidence of disease. In 12 patients with hypopharyngeal cancer tolerance of treatment and early results were poor, so the study was stopped in this group.

[Combined modality treatment with chemotherapy followed by surgery with immediate reconstruction and irradiation for primary unresectable oral cavity cancer]. / Ocena tolerancji indukcyjnej chemioterapii, leczenia operacyjnego z natychmiastowa rekonstrukcja i uzupelniajacej radioterapii u chorych na pierwotnie nieoperacyjnego raka jamy ustnej.

In the Head and Neck Cancer Department of Cancer in Warsaw between August 1997 and September 1998 twenty patients with primary unresectable oral cavity cancer were referred for combined modality treatment with cisplatin based chemotherapy followed by wide resection (in the case of tumor regression) with immediate reconstruction and adjuvant radiotherapy. Tumor regression after chemotherapy was obtained in 15 patients and all of them were referred to surgery; wide resection and reconstruction using pectoralis major (PM) flap. 14 patients completed all treatment protocol, also with adjuvant radiotherapy. Tolerance of treatment was excellent and there was no influence of chemo- and radiotherapy for adaptation of PM flaps. During observation local recurrence was observed in two cases. Twelve patients are alive without evidence of disease. Study is continued.

[Early results of combined treatment (induction chemotherapy and radiotherapy) of patients with squamous cell carcinoma of the oropharynx]. / Wczesne wyniki leczenia skojarzonego (chemioterapia indukcyjna i napromienianie) chorych na raka plaskonablonkowego gardla srodkowego.

The results of combined treatment (induction chemotherapy followed by irradiation) in 23 patients with locally advanced squamous cell carcinoma of the oropharynx were presented. Chemotherapy program included Cisplatin 100 mg/m2 i.v. in day 1 and 5-fluorouracil 750 mg/m2 i.v. on day 1-5. The chemotherapy was administered every 3 weeks for maximum 3 cycles. Complete response in 15 patients (65%), stabilization in 4 patients (17%) and progressive disease was found in 3 patients (14%). 20 patients were irradiated with radical intention. Complete response was found in 9 patients (45%) after radiotherapy. Treatment was relatively well-tolerated. Out of 17 patients with at least 6 months' follow-up (range 6-24) 6 patients are alive with no evidence of disease. We estimate the postirradiation reaction as slightly more severe than after radiotherapy alone. The reaction did not influence the prescribed way of fractionation.

A feasibility study of concomitant boost radiotherapy for patients with cancer of the supraglottic larynx.

Between February 1988 and December 1989, 65 patients with supraglottic cancer completed a course of concomitant boost radiotherapy. Cases with N3 disease, a Karnovsky performance score less than 70, age above 70 years, or a second primary cancer were not eligible for the study. Distribution of the patients was: Stage T1-T2 30%, T3-T4 70%, N0 68%, N+ 32%. The total dose ranged from 60 Gy to 76 Gy (median 66 Gy); overall treatment time ranged from 36 to 56 days with a median of 42 days. The daily dose during the first 4 weeks was 1.8 Gy, and during the last 2 weeks it was 1.6 Gy b.i.d. with a 4- or (after September 1988) 6-h interval. The clinical impression was that the early mucosal reactions were acceptable but more severe than after conventional treatment, with confluent membranous mucosal reaction being observed in 54% of the patients. Also, this reaction was significantly more frequent in patients treated with a 4-h interval (68%) than with a 6-h interval (41%) between the daily fractions. To relieve severe dysphagia, narcotics were required in 22% of the patients. The follow-up time ranged from 22 to 50 months, median 34 months. Treatment-requiring late complications were observed in 8 patients, and the 3-year actuarial risk was 17% with 95% confidence limits (6%, 27%). Two of these patients had severe complications: one of them required a temporary tracheostomy due to arytenoid edema and the other developed a laryngo-cutaneous fistula which healed after pharmacological treatment. Actuarial 3-year local-regional control was 59% (46%, 71%) and 3-year actuarial crude survival 55% (42%, 67%). There was no significant difference in the incidence of late complications or tumor control between the two groups of patients treated with a 4- or 6-h interval between the daily fractions. This study shows that the concomitant boost regimen tried here is feasible, but also stresses that the interval between dose fractions should be 6 h or more.