Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer.

PURPOSE: The aim of the study was to evaluate the efficacy and tolerance of pre-operative chemoradiotherapy with oral capecitabine in Greek patients with locally advanced, resectable rectal cancer. MATERIALS AND METHODS: Thirty patients, 16 men and 14 women with a median age of 58 years (range, 21-75 years), with potentially resectable T3NO (30%), T3N1 (53%) and T4NO-1 (17%) rectal cancer, were treated with capecitabine (825 mg/m(2), twice daily for 7 days/week) and concomitant radiotherapy (50.4 Gy/28 fractions) for 5.5 weeks. Patients underwent surgery with total mesorectal excision 4-6 weeks later followed by 4-months of post-operative treatment with capecitabine. The primary end-point was to determine the clinical and pathological response, safety profile, preservation of the sphincter mechanism and rate of peri-operative complications. RESULTS: The median distance of rectal tumors from the anal verge was 7 cm. All patients had curative resection. Downstaging rate was 84% (25/30) on endorectal ultrasonography and 75% (22/30) on pathology findings. Pathological complete response rate was 23% (7/30). No patient had grade 4 toxicity. Grade 3 toxicity occurred in 3 patients (10%) and consisted mainly of leucopenia (6%) and hand-foot syndrome (4%). Mild or moderate toxicity was frequent, but always reversible. Twenty-four patients (80%) received sphincter-preserving surgical procedures. Peni-operative complications were seen in 6 (20%) patients and included mechanical ileus (3%), delayed wound healing (7%), wound infection (7%) and anastomotic leakage (3%). CONCLUSION: Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer achieves significant rates of tumor downstaging and sphincter preservation with a favorable safety profile.

Randomized phase II study of temozolomide and radiotherapy compared with radiotherapy alone in newly diagnosed glioblastoma multiforme.

PURPOSE: Surgery remains the standard treatment for glioma, followed by radiotherapy (RT) with or without chemotherapy. Despite multidisciplinary approaches, the median survival time for patients with glioblastoma multiform (GBM) remains at less than 1 year from initial diagnosis. Temozolomide (TMZ), an oral alkylating agent, has shown promising activity in the treatment of malignant gliomas. We conducted a multicenter randomized phase II study comparing the efficacy and safety of TMZ administered concomitantly and sequentially to RT versus RT alone in patients with newly diagnosed GBM. PATIENTS AND METHODS: One hundred thirty patients with pathologically confirmed, newly diagnosed GBM were randomly assigned (110 assessable patients) to receive either TMZ 75 mg/m(2)/d orally, concomitantly with RT (60 Gy in 30 fractions; group A, n = 57), followed by six cycles of TMZ (150 mg/m(2) on days 1 through 5 and 15 to 19 every 28 days), or RT alone (60 Gy in 30 fractions; group B, n = 53). RESULTS: Median time to progression was 10.8 months in group A and 5.2 months in group B (P = .0001). One-year progression-free survival rate was 36.6% in group A and 7.7% in group B. Median overall survival (OS) time was also significantly better in group A versus group B (13.4 v 7.7 months, respectively; P < .0001), as was the 1-year OS at 56.3% v 15.7% (P < .0001), respectively. Toxicity was mainly hematologic. One patient with grade 4 myelotoxicity died as a result of sepsis. The other side effects were mild. CONCLUSION: TMZ combined with RT (concomitantly and sequentially) seems to be more effective than RT alone in patients with newly diagnosed GBM. The combined-modality treatment was well tolerated.