Thirty-nine tumor-bearing patients with metastatic melanoma were treated with 3 subcutaneous injections of the MAGE-3.A1 peptide at monthly intervals. No significant toxicity was observed. Of the 25 patients who received the complete treatment, 7 displayed significant tumor regressions. All but one of these regressions involved cutaneous metastases. Three regressions were complete and 2 of these led to a disease-free state, which persisted for more than 2 years after the beginning of treatment. No evidence for a cytolytic T lymphocyte (CTL) response was found in the blood of the 4 patients who were analyzed, including 2 who displayed complete tumor regression. Our results suggest that injection of the MAGE-3.A1 peptide induced tumor regression in a significant number of the patients, even though no massive CTL response was produced. Int.

PURPOSE Nivolumab was assessed in patients with virus-associated tumors in the phase I/II CheckMate 358 trial (ClinicalTrials.gov identifier: NCT02488759 ). We report on patients with recurrent/metastatic cervical, vaginal, or vulvar cancers. PATIENTS AND METHODS Patients received nivolumab 240 mg every 2 weeks. Although patients with unknown human papillomavirus status were enrolled, patients known to have human papillomavirus–negative tumors were ineligible. The primary end point was objective response rate. Duration of response (DOR), progression-free survival, and overall survival were secondary end points. Safety and patient-reported outcomes were exploratory end points. RESULTS Twenty-four patients (cervical, n = 19; vaginal/vulvar, n = 5) were enrolled. Most patients had received prior systemic therapy for metastatic disease (cervical, 78.9%; vaginal/vulvar, 80.0%). Objective response rates were 26.3% (95% CI, 9.1 to 51.2) for cervical cancer and 20.0% (95% CI, 0.5 to 71.6) for vaginal/vulvar cancers. At a median follow-up of 19.2 months, median DOR was not reached (range, 23.3 to 29.5+ months; + indicates a censored observation) in the five responding patients in the cervical cohort; the DOR was 5.0 months in the single responding patient in the vaginal/vulvar cohort. Median overall survival was 21.9 months (95% CI, 15.1 months to not reached) among patients with cervical cancer. Any-grade treatment-related adverse events were reported in 12 of 19 patients (63.2%) in the cervical cohort and all five patients in the vaginal/vulvar cohort; there were no treatment-related deaths. In the cervical cohort, nivolumab treatment generally resulted in stabilization of patient-reported outcomes associated with health status and health-related quality of life. CONCLUSION The efficacy of nivolumab in patients with recurrent/metastatic cervical and vaginal or vulvar cancers is promising and warrants additional investigation. No new safety signals were identified with nivolumab treatment in this population.

The objective was to validate the use of the proposed International Statistical Classification of Diseases and Related Health Problems (10th revision) (ICD-10) criteria for fatigue (P-ICD10) through comparison with the Functional Assessment of Cancer Therapy Fatigue (FACT-F) subscale and three visual analogue scale (VAS) qualities in cancer patients thought to be fatigued. Fatigue was assessed in 834 cancer patients at three clinical centres in Belgium, using P-ICD10, FACT-F, and VAS to assess: level of energy (VAS1), quality of life (VAS2), and ability to perform daily activities (VAS3). Of the 834 interviewed cancer patients, 54% were classified as fatigued by the P-ICD10 criteria. Internal consistency of P-ICD10 was very good (alpha coefficient 0.82). The principal component analysis corroborated good internal consistency with all variables included in the first component; a second component was used to identify psychological fatigue (concentration and short-term memory disabilities). An abridged set of screening tools based on the first three general symptoms of the P-ICD10 is proposed with 100% specificity and 86% specificity, respectively. There was a marked decrease in FACT-F and VAS1 scores in patients diagnosed as fatigued by the P-ICD10 (mean+/-SD, FACT-F 20+/-9 vs 39+/-8, VAS1 34+/-21 vs 61+/-21). A logistic regression model between P-ICD10 criteria diagnosis and FACT-F (VAS1) identified a score of 34 (61) on the FACT-F scale as a proposed cut-off point for the diagnosis of fatigue. The ICD-10 criteria can be recommended as a diagnostic tool, whereas the FACT-F scale and the level of energy 100-mm VAS assess the intensity of fatigue, and are more suitable for follow-up of cancer-related fatigue.