Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer.

BACKGROUND: A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy. METHODS: We randomly assigned 501 patients (all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were candidates for organ preservation) to receive either TPF or PF induction chemotherapy, followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week. The primary end point was overall survival. RESULTS: With a minimum of 2 years of follow-up (> or =3 years for 69% of patients), significantly more patients survived in the TPF group than in the PF group (hazard ratio for death, 0.70; P=0.006). Estimates of overall survival at 3 years were 62% in the TPF group and 48% in the PF group; the median overall survival was 71 months and 30 months, respectively (P=0.006). There was better locoregional control in the TPF group than in the PF group (P=0.04), but the incidence of distant metastases in the two groups did not differ significantly (P=0.14). Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group. CONCLUSIONS: Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy. (ClinicalTrials.gov number, NCT00273546 [ClinicalTrials.gov].).

Patients' perceptions of quality of life after treatment for early prostate cancer.

PURPOSE: Treatment for early prostate cancer produces problematic physical side effects, but prior studies have found little influence on patients' perceived health status. We examined psychosocial outcomes of treatment for early prostate cancer. PATIENTS AND METHODS: Patients with previously treated prostate cancer and a reference group of men with a normal prostate-specific antigen (PSA) level and no history of prostate cancer completed questionnaires. Innovative scales assessed behavioral consequences of urinary dysfunction, sexuality, health worry, PSA concern, perceived cancer control, treatment decision making, decision regret, and cancer-related outlook. Urinary, bowel, and sexual dysfunction were assessed with symptom indexes; health status was assessed by the Physical and Mental Summaries of the Short Form (SF-12) Health Survey. RESULTS: Compared with men without prostate cancer, prostate cancer patients reported greater urinary, bowel, and sexual dysfunction, but similar health status. They reported worse problems of urinary control, sexual intimacy and confidence, and masculinity, and greater PSA concern. Perceptions of cancer control and treatment decisions were positive, but varied by treatment: prostatectomy patients indicated the highest and observation patients indicated the lowest cancer control. Bowel and sexual dysfunction were associated with poorer sexual intimacy, masculinity, and perceived cancer control; masculinity and PSA concern were associated with greater confidence in treatment choice; and diminished sexual intimacy and less interest in PSA were associated with greater regret. CONCLUSION: The lack of change in global measures of health status after treatment for early prostate cancer obscures important influences in men's lives; cancer diagnosis and treatment complications may result in complex outcomes. Aggressive treatment may confer confidence in cancer control, yet be countered by diminished intimate relationships and masculinity, which accompany sexual dysfunction.

Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer.

BACKGROUND: We performed a prospective, randomized study in patients with previously untreated advanced (Stage III or IV) laryngeal squamous carcinoma to compare the results of induction chemotherapy followed by definitive radiation therapy with those of conventional laryngectomy and postoperative radiation. METHODS: Three hundred thirty-two patients were randomly assigned to receive either three cycles of chemotherapy (cisplatin and fluorouracil) and radiation therapy or surgery and radiation therapy. The clinical tumor response was assessed after two cycles of chemotherapy, and patients with a response received a third cycle followed by definitive radiation therapy (6600 to 7600 cGy). Patients in whom ther was no tumor response or who had locally recurrent cancers after chemotherapy and radiation therapy underwent salvage laryngectomy. RESULTS: After two cycles of chemotherapy, the clinical tumor response was complete in 31 percent of the patients and partial in 54 percent. After a median follow-up of 33 months, the estimated 2-year survival was 68 percent (95 percent confidence interval, 60 to 76 percent) for both treatment groups (P = 0.9846). Patterns of recurrence differed significantly between the two groups, with more local recurrences (P = 0.0005) and fewer distant metastases (P = 0.016) in the chemotherapy group than in the surgery group. A total of 59 patients in the chemotherapy group (36 percent) required total laryngectomy. The larynx was preserved in 64 percent of the patients overall and 64 percent of the patients who were alive and free of disease. CONCLUSIONS: These preliminary results suggest a new role for chemotherapy in patients with advanced laryngeal cancer and indicate that a treatment strategy involving induction chemotherapy and definitive radiation therapy can be effective in preserving the larynx in a high percentage of patients, without compromising overall survival.