Stereotactic body radiotherapy in oligometastatic cervical cancer (MITO-RT2/RAD study): a collaboration of MITO, AIRO GYN, and MaNGO groups.

OBJECTIVE: This retrospective, multicenter study analyzes the efficacy and safety of stereotactic body radiotherapy in a large cohort of patients with oligometastatic/persistent/recurrent cervical cancer. METHODS: A standardized data collection from several radiotherapy centers that treated patients by stereotactic body radiotherapy between March 2006 and February 2021 was set up. Clinical and stereotactic body radiotherapy parameters were collected. Objective response rate was defined as a composite of complete and partial response, while clinical benefit included objective response rate plus stable disease. Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer and Common Terminology Criteria for Adverse Events scales were used to grade toxicities. The primary endpoints were the rate of complete response to stereotactic body radiotherapy, and the 2 year actuarial local control rate on a 'per lesion' basis. The secondary end points were progression-free survival and overall survival, as well as toxicity. RESULTS: A total of 83 patients with oligometastatic/persistent/recurrent cervical cancer bearing 125 lesions treated by stereotactic body radiotherapy at 15 different centers were selected for analysis. Of the sites of metastatic disease, lymph node metastases were most common (55.2%), followed by parenchyma lesions (44.8%). Median total dose was 35 Gy (range 10-60), in five fractions (range 1-10), with a median dose/fraction of 7 Gy (range 4-26). Complete, partial, and stable response were found in 73 (58.4%), 29 (23.2%), and 16 (12.8%) lesions, respectively, reaching 94.4% of the clinical benefit rate. Forty-six (55.4%) patients had a complete response. Patients achieving complete response on a 'per lesion' basis experienced a 2 year actuarial local control rate of 89.0% versus 22.1% in lesions not achieving complete response (p<0.001). The 2 year actuarial progression-free survival rate was 42.5% in patients with complete response versus 7.8% in patients with partial response or stable or progressive disease (p=0.001). The 2 year actuarial overall survival rate was 68.9% in patients with complete response versus 44.3% in patients with partial response or stable or progressive disease (p=0.015). Fifteen patients (18.1%) had mild acute toxicity, totaling 29 side events. Late toxicity was documented in four patients (4.8%) totaling seven adverse events. CONCLUSION: Our analysis confirmed the efficacy of stereotactic body radiotherapy in oligometastatic/persistent/recurrent cervical cancer patients. The low toxicity profile encourages the wider use of stereotactic body radiotherapy in this setting.

Prevalence and influence of malnutrition on quality of life and performance status in patients with locally advanced head and neck cancer before treatment.

GOALS OF WORK: The aim of this study was to evaluate the prevalence and influence of malnutrition (unintentional weight loss >or=5% in the last 3 months) on quality of life (QoL) and performance status (PS) in head and neck cancer patients (HNC) before treatment. PATIENTS AND METHODS: Sixty-one consecutive outpatients affected by locally advanced HNC (III-IVA stage) were enrolled. In all patients, nutritional intake (by diet history), nutritional status (Patient Generated Subjective Global Assessment), unintentional weight loss (UWL), serum prealbumin, hemoglobin level (Hb), C-reactive protein, QoL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 v. 3.0), and PS (Eastern Cooperative Oncology Group (ECOG) PS) were assessed before radio or concomitant chemoradiotherapy. MAIN RESULTS: Thirty-six percent of HNC were malnourished before treatment. The median ECOG PS in malnourished patients was 1 (0-2), whereas in nonmalnourished was 0 (0-2; p = 0.018). Physical (p = 0.043), role (p = 0.047), and social functions (p = 0.024) scores were significantly worse in malnourished than in nonmalnourished HNC. Fatigue (p < 0.001), appetite loss (p < 0.001), and nausea and vomiting (p = 0.002) scores were worse in malnourished patients than in nonmalnourished. In the multivariate analysis, UWL and Hb level independently influenced physical (p = 0.002; p = 0.005), role (p = 0.004; p = 0.001), and social functions (p = 0.024; p = 0.009). CONCLUSION: Our data suggest that an early and intensive nutritional support might reduce weight loss before, during, and after treatment completion, improving outcome, QoL, and PS.

Stereotactic radiosurgery combined with nivolumab or Ipilimumab for patients with melanoma brain metastases: evaluation of brain control and toxicity.

PURPOSE: To investigate the efficacy and safety of concurrent stereotactic radiosurgery (SRS) and ipilimumab or nivolumab in patients with untreated melanoma brain metastases. PATIENTS AND METHODS: Eighty consecutive patients with 326 melanoma brain metastases receiving SRS in combination with ipilimumab or nivolumab were identified from an institutional database and retrospectively evaluated. Patients started systemic treatment with intravenous nivolumab or ipilimumab within one week of receiving SRS. Nivolumab was given at doses of 3 mg/kg every two weeks. Ipilimumab was administered up to four doses of 10 mg/kg, one every 3 weeks, then patients had a maintenance dose of 10 mg/kg every 12 weeks, until disease progression or inacceptable toxicity. Primary endpoint of the study was intracranial progression-free survival (PFS). Secondary endpoints were extracranial PFS, overall survival (OS), and neurological toxicity. RESULTS: Eighty patients were analyzed. Forty-five patients received SRS and ipilimumab, and 35 patients received SRS and nivolumab. With a median follow-up of 15 months, the 6-month and 12-month intracranial PFS rates were 69% (95%CI,54-87%) and 42% (95%CI,24-65%) for patients receiving SRS and nivolumab and 48% (95%CI,34-64%) and 17% (95%CI,5-31%) for those treated with SRS and ipilimumab (p = 0.02), respectively. Extracranial PFS and OS were 37 and 78% in SRS and nivolumab group, respectively, and 17 and 68% in SRS and ipilimumab group, respectively, at 12 months. Sub-group analysis showed significantly better intracranial PFS for patients receiving multi-fraction SRS (3 × 9 Gy) compared to single-fraction SRS (70% versus 46% at 6 months, p = 0.01), especially in combination with nivolumab. Grade 3 treatment-related adverse events occurred in 11 (24%) patients treated with SRS and ipilimumab and 6 (17%) patients who received SRS and nivolumab. Radiation-induced brain necrosis (RN) occurred in 15% of patients. CONCLUSIONS: Concurrent SRS and ipilimumab or nivolumab show meaningful intracranial activity in patients with either asymptomatic and symptomatic melanoma brain metastases, although a subset of patients may develop symptomatic RN. The combination of nivolumab with SRS is associated with better intracranial control.

Influence of weight loss on outcomes in patients with head and neck cancer undergoing concomitant chemoradiotherapy.

BACKGROUND: The purpose of this study was to determine the influence of weight loss on outcome in patients with head and neck cancer undergoing concomitant chemoradiotherapy (CCRT): treatment interruption, infections, mortality, and hospital readmission rate. METHODS: Forty patients with head and neck cancer were enrolled. All patients were counseled to follow a nutritional program during CCRT. Body weight was evaluated at baseline, at the end, and 30 days after radiochemotherapy. RESULTS: Ninety percent of compliant patients with nutritional program maintained body weight (mean, 1 +/- 2.4 kg) and 100% of noncompliant patients continued to lose weight (mean, -9 +/- 4 kg; p < .001). A reduction greater than 20% of prediagnosis weight significantly correlated with treatment interruption (p = .003), infections (p = .002), early mortality (p = .011), hospital readmission rate (p = .001), and survival (log-rank test: z = -2.722, p = .006). CONCLUSION: In patients with head and neck cancer undergoing CCRT, the early nutritional management reduces weight loss and improve outcome.