Chemoradiation with concomitant boosts followed by radical surgery in locally advanced cervical cancer: long-term results of the ROMA-2 prospective phase 2 study.

PURPOSE: This prospective, phase 2 study aimed at assessing the efficacy of accelerated fractionation radiation therapy by concomitant boosts (CBs) associated with chemoradiation therapy (CRT) of the whole pelvis, in improving the rate of pathological complete response (pCR) to treatment in patients with International Federation of Gynaecology and Obstetrics (FIGO) stage IB2-IVA locally advanced cervical cancer. METHODS AND MATERIALS: Neoadjuvant CRT included conformal irradiation of the whole pelvis with a total dose of 39.6 Gy (1.8 cGy/fraction, 22 fractions), plus additional irradiation of primary tumor and parametria with 10.8 Gy administered with CBs (0.9 cGy/fraction, 12 fractions, every other day). Concomitant chemotherapy included cisplatin (20 mg/m(2), days 1-4 and 26-30 of treatment), and capecitabine (1300 mg/m(2)/daily, orally) during the first 2 and the last 2 weeks of treatment. Radical hysterectomy plus pelvic with or without aortic lymphadenectomy was performed within 6 to 8 weeks from CRT. Toxicity was recorded according to Radiation Therapy Oncology Group toxicity criteria and Chassagne grading system. Based on the Simon design, 103 cases were required, and the regimen would be considered active if >45 pCR were registered (α error = 0.05; ß error = 0.1). RESULTS: pCR was documented in 51 cases (50.5%), and the regimen was considered active, according to the planned statistical assumptions. At median follow-up of 36 months (range: 7-85 months), the 3-year local failure rate was 7%, whereas the 3-year disease-free and overall survival rates were 73.0% and 86.1%, respectively. Grade 3 leukopenia and neutropenia were reported in only 1 and 2 cases, respectively. Gastrointestinal toxicity was always grade 1 or 2. CONCLUSIONS: Addition of CBs in the accelerated fractionation modality to the whole pelvis chemoradiation followed by radical surgery results in a high rate of pathologically assessed complete response to CRT and a very encouraging local control rate, with acceptable toxicity.

Onco-geriatric approach for the management of older patients with cancer.

INTRODUCTION AND RATIONALE: The number of older cancer patients is increasing with global aging of the population. A close interaction between oncologists and geriatricians becomes necessary to (1) better evaluate the elders' health status, (2) determine their residual clinical/biological reserves, and (3) optimize the provided medical care. In fact, aggressive antineoplastic managements are often denied to older patients, possibly because of the common misconception suggesting older age and/or clinical complexity as absolute contraindications to advanced treatments. METHODS: The primary aim of the presented project is to assess whether assigning a geriatrician to provide daily medical care to older cancer patients (aged 65 years and older) admitted to an oncology ward increases the number of patients eligible for a chemotherapeutic and/or surgical intervention. The project is articulated in 2 phases: (1) a retrospective phase based on analysis of data collected over the 2 years before the beginning of the study, and (2) a prospective 2-year intervention. Additional information about clinical conditions, biological parameters, adverse drug reactions, body composition, physical function, and 1-year health-related events will also be recorded. OUTCOMES: The combination of expertise from oncologists and geriatricians is likely to result in (1) an improved selection of candidates for interventions aimed at increasing disability-free life expectancy and/or overall survival, and (2) a more rational exclusion of patients at higher risk of toxicity or with poor prognosis. In this article, the development of an onco-geriatric unit aimed at the evaluation, management, and treatment of older women with gynecological cancer is also described.

Perioperative morbidity and mortality in elderly gynecological oncological patients (>/= 70 Years) by the American Society of Anesthesiologists physical status classes.

BACKGROUND: We evaluated the morbidity and mortality associated with American Society of Anesthesiologists (ASA) classes III and IV versus ASA classes I and II in elderly women (>/= 70 years) undergoing gynecological oncological surgery. METHODS: From 1986 to 2000, we retrospectively collected patients >/= 70 years of age undergoing oncological gynecological surgery. The study population consisted of 121 ASA class III and IV patients. The control group consisted of the same number of patients with ASA classes I and II, and these were matched to study patients (1:1) by clinical and surgical data. The morbidity and mortality of patients with ASA status III and IV were analyzed before and after 1992. RESULTS: In ASA class III and IV patients, compared with ASA class I and II, a higher rate of severe morbidity (P =.000) occurred, whereas the median postoperative stay was similar (8 days). No differences between patients with ASA class III and IV and ASA class I and II for median operative time, transfusion rate, or median blood loss were found. Mortality was 3% in ASA classes III and IV. CONCLUSIONS: Our study suggests that surgery in elderly gynecological oncological patients aged >/= 70 years with ASA class III or IV results in an acceptable perioperative morbidity and mortality rate.