It has been postulated that monitoring measurable residual disease (MRD) could be used as a surrogate marker of progression-free survival (PFS) in chronic lymphocytic leukemia (CLL) patients after treatment with immunochemotherapy regimens. In this study, we analyzed the outcome of 84 patients at 3 years of follow-up after first-line treatment with fludarabine, cyclophosphamide and rituximab (FCR) induction followed by 36 months of rituximab maintenance thearpy. MRD was assessed by a quantitative four-color flow cytometry panel with a sensitivity level of 10−4. Eighty out of 84 evaluable patients (95.2%) achieved at least a partial response or better at the end of induction. After clinical evaluation, 74 patients went into rituximab maintenance and the primary endpoint was assessed in the final analysis at 3 years of follow-up. Bone marrow (BM) MRD analysis was performed after the last planned induction course and every 6 months in cases with detectable residual disease during the 36 months of maintenance therapy. Thirty-seven patients (44%) did not have detectable residual disease in the BM prior to maintenance therapy. Interestingly, 29 patients with detectable residual disease in the BM after induction no longer had detectable disease in the BM following maintenance therapy. After a median followup of 6.30 years, the median overall survival (OS) and PFS had not been reached in patients with either undetectable or detectable residual disease in the BM, who had achieved a complete response at the time of starting maintenance therapy. Interestingly, univariate analysis showed that after rituximab maintenance OS was not affected by IGHV status (mutated vs. unmutated OS: 85.7% alive at 7.2 years vs. 79.6% alive at 7.3 years, respectively). As per protocol, 15 patients (17.8%), who achieved a complete response and undetectable peripheral blood and BM residual disease after four courses of induction, were allowed to stop fludarabine and cyclophosphamide and complete two additional courses of rituximab and continue with maintenance therapy for 18 cycles. Surprisingly, the outcome in this population was similar to that observed in patients who received the full six cycles of the induction regimen. These data show that, compared to historic controls, patients treated with FCR followed by rituximab maintenance have high-quality responses with fewer relapses and improved OS. The tolerability of this regime is favorable. Furthermore, attaining an early undetectable residual disease status could shorten the duration of chemoimmunotherapy, reducing toxicities and preventing long-term side effects. The analysis of BM MRD after fludarabine-based induction could be a powerful predictor of post-maintenance outcomes in patients with CLL undergoing rituximab maintenance and could be a valuable tool to identify patients at high risk of relapse, influencing further treatment strategies. This trial is registered with EudraCT n. 2007-002733-36 and ClinicalTrials.gov Identifier: NCT00545714.

Background: Chemotherapy-induced alopecia (CIA) is a distressing adverse effect of many chemotherapy (CT) agents. New strategies for prevention of CIA have been studied. Scalp cooling has been reported to prevent CIA. We conducted a retrospective study aimed to assess the efficacy of scalp cooling in preventing CIA among women receiveing chemotherapy for breast cancer. Methods: Was included clinical data of breast cancer patients at the Oncoclinicas Group from July/2015 to March/2017. All patients were elected to use scalp cooling to prevent CIA. Cooling started 30 minutes before infusion and was maintained throughout the infusion of the treatment and extended for 90 minutes after infusion. Degree of hair loss was rated by nurse assessment using CTCAE v4.0 scale in grade zero (without alopecia), 1 (<50%) or 2 (>50%), digital photographs and clinical assessment. Assessments were made before each chemotherapy treatment and at a follow up visit between 3 weeks and 3 months after the completion of chemotherapy. Success was defined when there was G0 or G1 alopecia at the end of the treatment, and failure when finished with G2 alopecia and patient withdrawal due to alopecia. Results: 330 patients were included. 283 with localized breast cancer and 47 with metastatic disease. 188 patients (57.0%) completed all tratment with scalp cooling. 72 patients (21.8%) withdrew from cryotherapy for alopecia of any degreee, 51 patients (15.4%) gave up cryotherapy for complaints unrelated to alopecia and 19 patients (5.8%) had their treatment interrupted due to external factors (progression of disease, change of CT protocol, among others). Among patients who completed chemotherapy (n=188), the degree of alopecia at the end was G0 = 27, G1 = 138, G2 = 23. Thus, the overall success rate with cryotherapy was 63.5%. CT protocols initiated with doxorubicin and cyclophosphamide, followed by taxanes, presented a success rate of 50%. The combintation of docetaxel and cyclophosphamide showed success of 71.9%. Scalp cooling: chemotherapy regimes and alopeciaChemotherapy (CT) regimeCompleted CT G0Completed CT G1Completed CT G2Abandoned SC G1Abandoned SC G2AC02011AC/taxanes65152527AC non sequential11100D alone or combi no AC319221DC6401134EC at 2nd part of CT01000EC at 1rst part of CT00111P alone or combi no AC613014No AC21000AC at 2nd part of CT310310Total27138233438A: doxorubicin; C: cyclophosphamide; D: docetaxel; E: epirubicin; P: paclitaxel; combi: combination In addition to alopecia, headache and cold sensation were common reasons for cryotherapy withdrawal. Conclusions: Scalp cooling appears to be effective in preventing CIA among breast cancer patients who underwent chemotherapy. Studies involving a psychological approach to the expectation and experience of alopecia with cryotherapy and better management of pain are necessary to increase adherence to treatment. Citation Format: Silva GB, Moreira RB, Gimenes DL, Silva ACP, Araújo BRC, Pacheco BP, Paiva RdCP, Sutmoller C, Hammermuller LMJ, Lima RO, Pimentel RVIA, Simões ÂAB, Mathias CMC, Lessa ÂMC, Costa MAD, Martins LCA, Ferrari BL. Efficacy of scalp cooling in preventing chemotherapy-induced alopecia in breast cancer patients: A retrospective, comprehensive review of 330 cases of Brazil [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-06.

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BackgroundThe optimal strategy for the treatment of recurrent and/or advanced endometrial cancer is still undefined. Recently, despite the lack of any predictive biomarker, the combination of pembrolizumab with lenvatinib has improved survival outcomes. We here report the long-term management of lung toxicity in a patient with endometrial cancer, and we critically review the current therapeutic options for this disease.ResultsA patient with heavily pretreated endometrial cancer took pembrolizumab plus lenvatinib for 1 year, achieving a persistent partial response with a time to treatment failure of 18 months, despite relevant lung toxicity that did not affect the remarkable overall clinical benefit. A systematic review of this combination underlines the efficacy outcome despite toxicity. Interestingly, the literature review on lung toxicity suggested the role of anti-angiogenetic agents in the pathogenesis of lung cavitation, probably related to direct treatment activity, and disclosed a potential radiological sign predictive of the activity of anti-angiogenetic agents.ConclusionWe underline the efficacy of pembrolizumab plus lenvatinib in the current treatment landscape of endometrial cancer, underscoring the relevance of a correct management of toxicity.