; on behalf of the Zoster-028 Study Group BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle. METHOD: In this phase 2/3 observer-blind, multicenter study (NCT01798056), patients with STs who were ≥18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 1-2 months apart and stratified (4:1) according to the timing of the first dose with respect to the start of a chemotherapy cycle (first vaccination 8-30 days before the start or at the start [±1 day] of a chemotherapy cycle). Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 + T cell frequencies, and vaccine response rates (VRRs) were assessed 1 month after dose 1 and 1 and 12 months after dose 2. Reactogenicity and safety were assessed in the total vaccinated cohort through 12 months after dose 2. RESULTS: There were 232 participants in the total vaccinated cohort, 185 participants in the according-to-protocol cohort for humoral immunogenicity, and 58 participants in the according-to-protocol cohort for cell-mediated immunogenicity. Postvaccination anti-gE antibody concentrations, gE-specific CD4 + T cell frequencies and VRRs were higher in RZV recipients than in placebo recipients. Solicited adverse events (AEs) were more frequent among RZV recipients than placebo recipients. Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune-mediated diseases were similar between RZV and placebo recipients. CONCLUSION: RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell-mediated immune responses persisted 1 year after vaccination. No safety concerns were identified.

ObjectivesOpioid-induced constipation (OIC) can affect up to 63% of all patients with cancer. The objectives of this study were to assess quality of life as well as efficacy and safety of naloxegol, in patients with cancer with OIC.MethodsAn observational study was made of a cohort of patients with cancer and with OIC exhibiting an inadequate response to laxatives and treated with naloxegol. The sample consisted of adult outpatients with a Karnofsky performance status score ≥50. The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) and the Patient Assessment of Constipation Symptoms (PAC-SYM) were applied for 3 months.ResultsA total of 126 patients (58.2% males) with a mean age of 61.3 years (range 34–89) were included. Clinically relevant improvements (>0.5 points) were recorded in the PAC-QOL and PAC-SYM questionnaires (p<0.0001) from 15 days of treatment. The number of days a week with complete spontaneous bowel movements increased significantly (p<0.0001) from 2.4 to 4.6 on day 15, 4.7 after 1 month and 5 after 3 months. Pain control significantly improved (p<0.0001) during follow-up. A total of 13.5% of the patients (17/126) presented some gastrointestinal adverse reaction, mostly of mild (62.5%) or moderate intensity (25%).ConclusionsClinically relevant improvements in OIC-related quality of life, number of bowel movements and constipation-related symptoms were recorded as early as after 15 days of treatment with naloxegol in patients with cancer and OIC, with a good safety profile.

ObjectivesNaloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study.MethodsThis one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky≥50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L).ResultsA total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Global QOL was conserved from baseline. A total of 28 adverse reactions, mainly gastrointestinal were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment.ConclusionThe results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.

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Background Circulating tumour cells (CTC) may be a good biomarker to guide the management of patients with LAMBC (Cristofanilli, NEJM 2004). Detection of CTCs in peripheral blood is a simple procedure. Eribulin monotherapy has shown improved survival in patients with LAMBC that has progressed after 2 or 3 chemotherapy regimens (EMBRACE study). The aims of this study were to evaluate the kinetics of CTCs before and after eribulin treatment, and its correlation with clinical outcomes. Methods Patients received eribulin (1.23 mg/m2 on days 1 and 8 of every 21-day cycle) as third-line therapy until progression, unacceptable toxicity or withdrawal. CTCs were measured in 7.5ml of blood at baseline and after the second cycle of treatment. Cell counting was performed using the CellSearch System, Veridex. Cox proportional hazards regression modeling was used to identify independent prognostic factors for survival endpoints. Results Out of 59 eligible women (mean age 57.7 years), 58 (98.3%) had received previous taxanes and/or anthracyclines. Nearly all (98.3%) had HER2-negative tumors, 72% were positive for estrogens, 21% were triple-negative; 64.4% had liver metastasis and 57.6% bone metastasis. The mean number of administered cycles was 6.9 ± 5.4. Follow-up was performed in 54 patients, with 18.5% (n=10) partial response, 42.6% (n=23) stable disease, and 38.9% (n=21) progressive disease. Clinical benefit was achieved in 33 patients (61.1%). Median progression-free survival (PFS) was 5.13 months (95% CI 3.23, 8.90) and median overall survival (OS) was 13.6 months (95% CI 11.8, not reached). CTC levels were measured in 50 patients. The mean number of CTCs at baseline was 16.8 (IQR 0-21) and on cycle 2, 5.4 (IQR 0-8.5), p&lt;0.001. In patients with CTC ≥ 5 at baseline, 52.4% reduced their levels to CTC &lt; 5 on cycle 2 (p=0.043). No significant differences (p=0.066) were found in PFS when baseline CTC levels were &lt; 5 or ≥ 5 cells/ml. Statistical differences were, however, found in OS (p= 0.0083). On cycle 2, significant differences were observed for both PFS (p=0.045) and OS (p=0.0129) with CTC levels &lt;5 or ≥ 5 cells/ml. No correlation could be found between CTC levels and the objective response at baseline or on cycle 2. Conclusions Our study suggests there is a significant correlation between levels of CTCs and disease prognosis. Eribulin monotherapy was related to a significant reduction in CTCs. (EudraCT number 2013-001416-30). Keywords eribulin, metastatic, breast cancer, circulating tumour cells. Citation Format: Manso Sánchez L, Moreno Antón F, Izarzugaza Perón Y, Delgado Mingorance I, Borrega García P, Echarri González MJ, Martínez Jáñez N, López González A, Olier Garate C, Ballesteros García A, Chacón López-Muñiz I, Ciruelos Gil EM, García Sáenz JA, Paz-Ares Rodríguez L. High reduction of circulating tumour cells in HER2-negative locally advanced or metastatic breast cancer (LAMBC) patients treated with eribulin as third line chemotherapy (ONSITE study) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P6-07-21.

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not receive a BTA reported significantly less pain and better QoL scores than those who were considered at 'low risk' but did receive BTA treatment or those considered at 'high risk' regardless of BTA treatment. Overall satisfaction with the treatment effect was good, with almost 50% of patients reporting that they were completely satisfied.Conclusions: Overall, pain and quality of life did not differ according to BTA treatment or physicians' risk perception. Patients with low risks not receiving BTA treatment reported the least pain and highest QoL scores. These results indicate that treating physicians assess bone complication risk appropriately and treat patients accordingly.Legal entity responsible for the study: Swiss Group for Clinical Cancer Research.

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