UNASSIGNED: Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are highly effective. Nevertheless, immunocompromised participants were excluded from randomized controlled clinical trials. This study evaluates the efficacy and safety of the Pfizer/BioNTech BNT162b2 (BNT162b2) vaccine in patients with breast and gynecological cancer treated with active anticancer therapy versus a control cohort of healthy participants.
UNASSIGNED: Immune responses to the BNT162b2 vaccine in patients with breast cancer (n = 44) or a gynecological malignancy (n = 6) on active anticancer therapy (28 on chemotherapy, mostly anthracycline- or taxane-based, and 22 on target therapy) and in a control cohort of participants without cancer (n = 67) were investigated by SARS-CoV-2 neutralizing antibody titers measured by S1-binding immunoglobulin G (IgG) concentrations assessed using the LIAISON XL tools (DiaSorin S.p.A.). Response was assessed after a second dose of the BNT162b2 vaccine administered before and at least 3 weeks after the vaccine dose.
UNASSIGNED: Overall, 43/50 (86%) patients of the cancer cohort (74% in the breast cancer group and 100% in the gynecological malignancy group) developed IgG antibodies after the second dose of the BNT162b2 vaccine. There were no statistically significant differences in responder rates between patients treated with chemotherapy and those on target therapy. The majority of patients who received chemotherapy with or without target therapy, 21/28 (75%), developed a reliable antibody titer after a vaccine. All seven non-responder patients were undergoing an anthracycline-based regimen. Based on IgG levels (0-400 AU/ml), patients were classified as negative (\'non-responders\'), weakly positive, or strongly positive (\'responders\'). No delay in cancer therapy schedule or reported side effects were recorded after BNT162b2 vaccine administration. All healthy participants were strongly positive. Responder rates differed significantly between the two study cohorts (p < 0.001).
UNASSIGNED: Most patients develop antibody titers after the second immunization. However, given the persistence of non-responders or weak responders, additional immunization booster seems to be required, along with proactive planning in the vaccination schedule, with vaccine administration spaced out over time with respect to chemotherapy.

OBJECTIVE: We evaluated local control and toxicity in patients receiving radiotherapy associated with immune check point inhibitors and analyzed which oligometastatic disease setting benefits the most from local ablation in terms of advantage in overall survival.
METHODS: We retrospectively identified 60 oligoprogressive patients treated with a PD-1 inhibitor in association with radiotherapy on the site of progression (119 lesions).
RESULTS: After a median follow-up of 11.7 months (range=1-39 months), we observed complete response (CR) in 45/119, partial response (RP) in 42/119, and stable disease (SD) in 30/119 patients. Nine radionecrotic events occurred. Two patients experienced grade 3 toxicities and 32 patients reported grade 2 toxicities. The number of radiologically evident metastatic organs in patients who received concomitant PD-1 inhibitors and radiotherapy showed a significant increase in survival (respectively, 73% after 12 months and 47% after 24 months) in patients with 0-3 metastatic organs compared to those with more than 3 organ sites involved (p<0.0001).
CONCLUSIONS: Radiotherapy associated with PD-1 inhibitors is overall safe and efficacious. Patients eligible for intensification of local treatments should have less or equal to 3 metastatic organ sites.

During the past 20 years, considerable improvement has occurred in the treatment of patients with locally advanced rectal cancer (LARC). With the introduction of multimodal treatment, refinements in preclinical staging and improvements in surgical skills, local relapse is no longer the major problem for patients with LARC. However, many patients die of metastatic disease. The present phase Ib study aimed to establish the maximum tolerated dose of everolimus combined with 5-fluorouracil and radiotherapy in patients with LARC.
Patients were sequentially assigned to 4 cohorts with an increasing dose of everolimus, starting from 14 days before 5-fluorouracil and radiotherapy and continuing throughout concomitant treatment. The secondary endpoints were the Dworak tumor regression grade, pathologic complete response rate, neoadjuvant rectal score, biomarker assessment (phosphorylated mTOR [mammalian target of rapamycin] protein and phosphorylated-p70S6K protein).
At the time of this report, 12 patients had been treated, and no dose-limiting toxicity was recorded. The most frequently reported acute toxicities were rectal tenesmus, skin rash, diarrhea, and dysuria. All 12 patients underwent curative R0 resection. Two patients had Dworak tumor regression grade 4 (pathologic complete response). No everolimus-related postoperative complications were observed. No relationship was found between biomarker expression and the clinicopathologic outcomes.
Although the addition of everolimus did not appear to worsen the toxicity of chemoradiation in patients with LARC, evaluation of its activity deserves further investigation in larger clinical trials.