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Biomedical subjects

John M Loré

Publications and source records attributed to John M Loré.

2 recordsLinked to original sources

Carcinoma of the head and neck: a 5- to 20-year experience with preoperative chemotherapy, uncompromised surgery, and selective radiotherapy.

BACKGROUND: A 5- to 20-year evaluation of preoperative chemotherapy uncompromised surgery and selective radiotherapy in stage III/IV head and neck squamous cell carcinoma. METHODS: Eighty-two consecutive patients, single surgeon previously untreated, operable, and resectable for cure. Sites included the oral cavity, oropharynx, larynx, and hypopharynx. Two chemotherapeutic regimens were used: initial regimen (A), cisplatin/bleomycin (n = 45 patients); revised regimen (B), cisplatin/5-fluorouracil (n = 37 patients). The extent of surgery was carefully documented before chemotherapy-tattoo when feasible. This forms a strict guide for uncompromised surgery. Selective postoperative radiotherapy was based on specific criteria. RESULTS: Minimum follow-up was 5 years. Absolute survival: total group, 60%; regimen A, 46%; and regimen B, 77% (P =.004). Relative survival (correcting for life table mortality): total group, 66%; regimen A, 50%; and regimen B, 83% (P =.003). Recurrences: primary site, n = 9 (regimen A, n = 7 [16%]; regimen B, n =2 [5%]) and neck, n = 6 (13%, all in regimen A). Distant metastasis occurred in 12 patients (10 [22%] in regimen A and 2 [5%] in regimen B). CONCLUSIONS: This study suggests treatment of advanced head and neck squamous cell carcinoma (resectable for cure) with preoperative chemotherapy (regimen B); resection of original tumor volume, regardless of response to chemotherapy; and selective (rather than routine) postoperative radiotherapy results in improved survival. More controlled studies are recommended.

Adult↗

Randomized controlled trials for evaluating surgical questions.

OBJECTIVE: To discuss some of the obstacles inherent in the design of the randomized controlled trial (RCT) that the surgeon must confront and options to minimize these obstacles. DATA SOURCES: The literature was searched for articles discussing RCTs using MEDLINE from 1966 to 1998. STUDY SELECTION: Studies relevant to the general use of RCTs for evaluating surgical questions were selected. SYNTHESIS: Several problems inherent in RCTs were noted: (1) ethical considerations, (2) difficulties in patient accrual, (3) patient preferences, and (4) variability in surgical proficiency/technique. Some means of minimizing these problems are (1) the concept of clinical equipoise, (2) multicenter trials, and (3) stratified sampling of patients. Alternatives to the classic RCT are discussed, namely, the randomized consent design and the patient preference design. CONCLUSIONS: The nature of the RCTs is that they are difficult to use to evaluate surgical techniques. Some options are available to minimize these difficulties. Designing and conducting RCTs to evaluate surgical interventions require careful planning and some compromises. Unless the previously mentioned criteria are applied, the validity of the RCT can be considered no greater than that of other trials.

Ethics, Medical↗