Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system.

PURPOSE: Mucositis occurs in almost all patients treated with radiotherapy for head and neck cancer. The aim of this multicenter, double-blind, prospective, randomized trial was to evaluate the clinical efficacy of an economically viable antimicrobial lozenge (bacitracin, clotrimazole, and gentamicin [BcoG]) in the alleviation of radiation-induced mucositis in patients with head and neck cancer. PATIENTS AND METHODS: One hundred thirty-seven eligible patients were randomized to treatment with either antimicrobial lozenge (69 patients) or placebo lozenge (68 patients). The primary end point of the study was the time to development of severe mucositis from the start of radiotherapy. Secondary end points included severity and duration of mucositis, pain measurement, radiation therapy interruption, and quality of life. Mucositis was scored using a validated mucositis scoring system. RESULTS: Toxicity profiles were similar between the two arms of the study. The median time to development of severe mucositis from the start of radiotherapy was 3.61 weeks on BCoG and 3.96 weeks on placebo (P =.61). There were no statistically significant differences between the arms in the extent of severe mucositis as measured by physician, in oral toxicities as recorded by patients, or in radiotherapy delays. CONCLUSION: This study was conducted on the basis of a pilot study that demonstrated the BCoG lozenge to be tolerable and microbiologically efficacious. A validated mucositis scoring system was used. However, in this group of patients treated with conventional radiotherapy, the lozenge did not impact significantly on the severity of mucositis. Whether such a lozenge would be beneficial in treatment situations where rate of severe mucositis is higher (ie, in patients treated with unconventional fractionation or with concomitant chemotherapy) is unknown.

Prognostic factors in limited rectal cancer treated with intracavitary irradiation.

At the Centre Georges-François Leclerc of Dijon, 91 limited rectal tumors received a complete intracavitary 50 kV contact radiotherapy alone or associated with interstitial brachytherapy according to the guidelines of J. Papillon. Nineteen had a villous adenoma and 72 a well or moderately differentiated rectal adenocarcinoma. The majority of patients had contra-indications for major surgical procedures. The median age was 70 years. Seventy-six percent (69/91) of the rectal tumors remained free from local recurrence. After salvage therapy, the local control was 91% (83/91). Sphincter preservation was obtained in 85% (77/91). "De novo" adenocarcinomas developed on pre-existing benign pathology and villous adenomas were not significantly different with regard to local control (76% resp. 75% versus 59.5%; p = 0.22). According to the Dijon clinical staging system, the local relapse-free survival at 5 years was 97% for CS T1A, 77% for CS T1B, 65% for CS T2A, and 60% for CS T2B. Tumors of the anterior rectal wall had a better local control rate than lateral and posterior primaries (100% versus 63% versus 67%). For the middle rectum, the local relapse-free survival was 94% compared to 54% of the upper and 77% of the lower rectum. Four additional patients had a preoperative intracavitary therapy and salvage surgery for incomplete tumor regression; the complete remission rate is 96% (91/95). Intracavitary radiotherapy alone is an effective treatment for limited rectal cancers. Contact X ray therapy can be used alone in CS T1A whereas a combination of contact X ray therapy and interstitial brachytherapy is often the optimal approach in CS T1B and CS T2A. In CS T2B, our data do not support the use of intracavitary techniques alone. In these cases, the sequence external irradiation followed by an interstitial implant seems of interest and deserves further evaluation with more patients and follow-up.

The Dijon clinical staging system for early rectal carcinomas amenable to intracavitary treatment techniques.

The Dijon clinical and endoscopic staging system for intracavitary radiotherapy of rectal cancer takes into account the size and the depth of penetration of the rectal wall. Its prognostic value was evaluated in a series of 72 patients with rectal adenocarcinoma treated at the Centre de Lutte Contre le Cancer G. F. Leclerc in Dijon: 30 presented with a clinical stage (CS) T1A (purely exophytic tumors of less than 3 cm). The 5-year local relapse-free actuarial survival (LRFS) was 97%. Fourteen patients with CS T1B (infiltrative component and less than 3 cm diameter) had a LRFS of 77%. Nine patients with CS T2A tumors (with larger exophytic tumors) has a LRFS of 65%. Nineteen CS T2B cases (larger than 3 cm with an infiltrative component) presented a LRFS of 60%. The size of the tumor and the clinical estimate of the infiltration of the rectal wall both have a significant prognostic value: adenocarcinoma of less than 3 cm (n = 44) had a LRFS of 93% versus 59% in larger ones (n = 39; p = less than 0.01). Free mobile lesions (n = 39) did better (n = 33; LRFS = 86%) than infiltrated tumors (n = 33; LRFS = 66%; p = 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

RTOG 0518: randomized phase III trial to evaluate zoledronic acid for prevention of osteoporosis and associated fractures in prostate cancer patients.

BACKGROUND: RTOG 0518 evaluated the potential benefit of zoledronic acid therapy in preventing bone fractures for patients with high grade and/or locally advanced, non-metastatic prostate adenocarcinoma receiving luteinizing hormone-releasing hormone (LHRH) agonist and radiotherapy (RT). METHODS: Eligible patients with T-scores of the hip (<-1.0, but >-2.5 vs >-1.0) and negative bone scans were prospectively randomized to either zoledronic acid, 4 mg, concurrently with the start of RT and then every six months for a total of 6 infusions (Arm 1) or observation (Arm 2). Vitamin D and calcium supplements were given to all patients. Secondary objectives included quality of life (QOL) and bone mineral density (BMD) changes over a period of three years. RESULTS: Of 109 patients accrued before early closure, 96 were eligible. Median follow-up was 36.3 months for Arm 1 and 34.8 months for Arm 2. Only two patients experienced a bone fracture (one in each arm) resulting in no difference in freedom from any bone fracture (P=0.95), nor in QOL. BMD percent changes from baseline to 36 months were statistically improved with the use of zoledronic acid compared to observation for the lumbar spine (6% vs -5%, P<0.0001), left total hip (1% vs -8%, P=0.0002), and left femoral neck (3% vs -8%, P=0.0007). CONCLUSIONS: For patients with advanced, non-metastatic prostate cancer receiving LHRH agonist and RT, the use of zoledronic acid was associated with statistically improved BMD percent changes. The small number of accrued patients resulted in decreased statistical power to detect any differences in the incidence of bone fractures or QOL.

[Para-clinical tests and follow-up of breast cancer: how do Quebec oncologists use them?]. / Examens para-cliniques et suivi du cancer du sein: quel usage les oncologues du Québec en font-ils?

To assess the use of complementary tests by oncologists during staging and follow-up of breast cancer patients, a study was performed comparing actual procedures with current literature recommendations. A survey concerning the use of biochemical, radiological and radionuclide tests was presented to a sample of 58 radiation oncologists and medical oncologists involved in the treatment of breast cancer patients, with a 71% response rate. During the post-treatment surveillance, respectively 3%, 24%, 37%, 76% and 96% of the physicians scheduled liver scans, liver ultrasounds, bone scans, chest roentgenograms or mammograms on a regular basis. The frequency of use of various procedures are reported with a reference to the cost-benefit ratio, a matter of current interest. Although most oncologists limit their use of diagnostic tests, some still rely on extensive work-up to detect early recurrences or metastases, an approach that remains controversial in today's literature.

Results of endocavitary irradiation of early rectal tumors.

At the C. G. F. Leclerc, Dijon, 91 early rectal tumors were treated with intracavitary contact radiotherapy alone or in combination with interstitial brachytherapy. The median age of the patients was 70 years. Most of them were referred because of poor surgical risk. Preservation of the sphincter was obtained in 85% (77/91). The actuarial local relapse-free survival rate at 5 years was 74% (67/91). No significant difference was seen between the 72 adenocarcinomas and 19 villous adenomas (p = 0.12). For the middle rectum the rate was 94% compared to 54% for the upper and 77% for the lower rectum. Anterior primaries fared better than posterior and lateral tumors (100%, 63%, and 67% respectively). After salvage therapy the local control rate raised to 91% (83/91). The clinical and endoscopic staging system of Dijon was of prognostic significance: T1A adenocarcinomas (purely exophytic tumors of less than 3 cm) had a better 5-year local relapse-free survival rate (97%) than T2A, T1B or T2B (p less than 0.01).

[Prevention of second primary cancer with vitamin supplementation in patients treated for head and neck cancers]. / Prévention des seconds cancers primaires par supplémentation vitaminique chez les patients traités pour un cancer ORL.

Second primary cancers often occur in head and neck cancer patients successfully treated by radiation therapy. Experimental and epidemiological data suggest that these second primaries might be prevented by antioxidant vitamins, in particular beta-carotene and alpha-tocopherol. A randomized double-blind clinical trial is being conducted in Canada to determine whether vitamin supplementation with beta-carotene (30 mg/d) and alpha-tocopherol (400 IU/d) reduces the incidence of second primaries in head and neck cancer patients treated by radiation therapy.

[Incidence and risk factors of second primary cancers in patients treated for primary pharyngeal cancer]. / Incidence et facteurs de risque de seconds cancers primaires chez les patients traités pour un premier cancer du pharynx.

About 13% of patients treated for a pharyngeal cancer suffer from a second primary cancer. Excessive consumptions of tobacco and/or alcohol are recognized as risk factors of second primary cancers in these patients. Epidemiologic studies suggest that antioxidant vitamins could have a protective effect on the occurrence of second primary cancers; however, this hypothesis should be confirmed by randomized clinical trials. A better knowledge of the risk factors of second primary cancers in patients with a pharyngeal cancer could help reducing the occurrence of second primary cancers and improving the follow-up of these patients.