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Radiochemotherapy Plus Chemotherapy Provides Effective Treatment for Invasive Bladder Cancer: Presented at ICACT

By Chris Berrie

PARIS, FRANCE -- February 4, 2005 -- A combined radiochemotherapy treatment that includes cisplatin and 5-fluorouracil provides high response rates and shows promise as an alternative approach to radical cystectomy in patients with muscle-invasive bladder carcinoma, according to a study presented here February 3^rd at the 16^th International Conference on Anti-Cancer Treatment.

Organ preservation as an alternative to radical cystectomy in the treatment of muscle-invasive bladder cancer has emerged as an important option in the last decade. However, despite various studies involving trimodal schedules that include transurethral resection (TUR) of the bladder tumour, radiotherapy and chemotherapy, the best combination remained to be identified, said Donatella Tirindelli Danesi, MD, Chief, Section of Biomedical Sciences, ENEA Casaccia, Rome, Italy.

Her team of researchers thus started a radiotherapy programme in 1992 with the aim of demonstrating that organ-sparing approaches are feasible and safe, and to test an innovative schedule of combined radiochemotherapy. Dr. Tirindelli Danesi reported the results of this programme following their recent publication (December 2004: Cancer, 2004, 101, 2540-2548).

The 77 patients enrolled in this study were divided into two groups according to the inclusion or exclusion of two rounds of induction systemic chemotherapy. The 42 patients in the treatment arm (male, 86%) had a median age of 64.3 years (range, 46-75 years) and the 35 control patients (male, 89%) had a median age of 65.5 years (range, 43-82 years). Tumour staging in the two groups was T₂ (52%, 77%, respectively) or T_3-4a, and histological grading was G₂ (51%, 46%, respectively) or G₃.

All patients underwent macroscopic aggressive TUR of the tumour and the bladder mapping. The treatment arm received two cycles of methotrexate IV 25 mg/m², cisplatin IV 80-100 mg/m² and vinblastin IV 100 mg/m² (MCV). Both patient groups then received Radiochemotherapy, consisting of cisplatin and 5-fluorouracil.

Complete responders who had superficial local recurrences during follow-up underwent endovascular therapy, while those with infiltrating local recurrences and partial responders were recommended for salvage cystectomy.

Radiochemotherapy included hyperfractionated radiotherapy at a dose of 100 cGy three times daily or 150 cGy two times daily. These gave a total dose of about 70 Gy, with 50 to 51 Gy to the whole pelvis and 19.5 to 20.0 Gy to the bladder. The combined chemotherapy regimen consisted of cisplatin 4 to 6 mg/m²/day and 5-fluorouracil 180 to 220 mg/m²/day by concomitant protracted intravenous infusion during the course of radiotherapy.

Following this treatment period, the combined complete response (CR) rate was 90.3 %, with 84.6% among MCV-treated patients and 97.0% in controls.

"Here we can see that the administration of the induction chemotherapy did not influence the percentages of the complete responses, and indeed, it was the MCV- patients that showed the higher complete response," Dr. Tirindelli Danesi said.

This response data did not include three patients who died from other causes (stroke/myocardial infarction), one who died as a result of treatment toxicity, and one who died suddenly of hepatic disease after treatment completion.

For the other potential influencing factors, Dr. Tirindelli Danesi said that only the tumour stage reached significance in terms of the complete response (T₂, 95.7%, T_3-4a, 80.0%; P =.045). There were also no significant differences between treatment groups in the World Health Organisation grade 3 and 4 toxicities.

Similarly, overall, tumour-specific, bladder-intact and cystectomy-free 5-year survivals reached 58.5%, 75.5%, 46.6% and 76.1%, respectively, there were again no differences seen between the treatment groups.

Dr. Tirindelli Danesi indicated that the researchers were ultimately not completely satisfied with the results, saying, "This is because our patients who were partial responders had a very bad prognosis, so we need to improve the therapeutic index by studying further the pretreatment prognostic factors." They would also recommend that the two MCV cycles be omitted in future studies, as these did not provide any patient benefits.


[Study Title: Conservative Treatment of Invasive Bladder Cancer by Radiochemotherapy. Long-Term Results.]

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