Because of their efficacy against numerous cancers, immune-checkpoint inhibitors (ICIs), anti-cytotoxic T-lymphocyte antigen-4, and anti-programmed cell death monoclonal antibodies are being used ever more often in oncology. However, some patients were excluded from clinical trials because of their comorbidities despite their potentially higher cancer frequencies, as is the case for immunocompromised patients. Areas covered: We analyzed reported preclinical and clinical information and evaluated the risk/benefit ratio for four immunocompromised populations: people living with human immunodeficiency virus (PLHs), solid-organ transplant recipients, recipients of hematopoietic stem-cell allografts, and patients with autoimmune diseases. Expert commentary: Information available in the literature is fragmentary and scarce, making it difficult to evaluate the risk/benefit ratio. It can, nonetheless, be noted that ICI use in PLHs seems possible. For solid-organ transplant recipients, the risk for the graft seems elevated. For the other two populations, it is difficult to conclude at this time.
, additive, not mandatory plasma samples were collected and analyzed at the time of revaluations. To determine changes in the risk level during follow-up, we evaluated changes in the probability of having progressive disease after two consecutive MSC tests, considering all possible combinations. Result: Overall 17 (34%) R, 17 (34%) patients with SD, 11 (22%) P and 5 (10%) not evaluable patients were identified. Considering the baseline blood samples 11 (22%) NSCLC patients were MSC H. ORR was 0% in MSC H vs 45% for other patients (p¼0.0090). Median PFS was 2.3 months for MSC H vs 10.9 months for other patients (HR¼0.38; 95%CI¼0.17-0.84; p¼0.0174). Median OS was 2.9 months for MSC H vs 22.0 months for other patients (HR¼0.18; 95%CI¼0.07-0.47; p¼0.0004). Data remained significant adjusting for age, sex, pack-years and ECOG performance status: PFS HR¼0.31 (95%CI¼0.13-0.73; p¼0.0072) and OS HR¼0.13 (95%CI¼0.04-0.39; p¼0.0003). Among the 26 patients with longitudinal evaluation of MSC risk level, all the 12 patients reaching progression during treatment showed an increase in the risk level (Sign-test p-value¼0.0039). Conversely, when considering the 14 NSCLC patients still maintaining SD or responding to ICIs at the time of the analysis, the risk level decreased for 9 (64%) of them (Sign-test p-value¼0.1655). Conclusion: These preliminary results suggest that MSC risk level at the baseline and during treatment could help to identify primary or secondary resistance in PD-L150% NSCLC patients treated with ICIs. Ongoing clinical trials are validating these results.
Background: Pembrolizumab combined with chemotherapy is now first-line standard of care in advanced non-small cell lung cancer. This real-life study aimed to assess efficacy and safety of carboplatin-pemetrexed plus pembrolizumab in advanced non-squamous non-small cell lung cancer.Methods: CAP29 is a retrospective, observational, multicenter real-life study conducted in 6 French centers. We evaluated efficacy of first-line setting chemotherapy plus pembrolizumab (November 2019 to September 2020) in advanced (stage III-IV) non-squamous non-small cell lung cancer patients without targetable alterations. Primary endpoint was progression-free survival. Secondary endpoints were overall survival, objective response rate and safety.Results: With a median follow-up of 4.5 months (0 to 22 months), a total of 121 patients were included. Baseline characteristics were: median age of 59.8 years with 7.4% ≥75 years, 58.7% of males, 91.8% PS 0-1, 87.6% of stage IV with ≥3 metastatic sites in 62% of cases. Patients had brain and liver metastases in 24% and 15.7% of cases, respectively. PD-L1 was <1% (44.6%), 1-49% (28.1%) and ≥50% (21.5%). Median progression-free survival and overall survival achieved 9 and 20.6 months, respectively. Objective response rate was 63.7% with 7 prolonged complete responses. Survival benefit seemed to be correlated with PD-L1 expression. Brain and liver metastases were not statistically associated with decreased overall survival. Most common adverse events were asthenia (76%), anemia (61.2%), nausea (53.7%), decreased appetite (37.2%) and liver cytolysis (34.7%). Renal and hepatic disorders were the main causes of pemetrexed discontinuation.Grade 3-4 adverse events concerned 17.5% of patients. Two treatment-related deaths were reported.Conclusions: First-line pembrolizumab plus chemotherapy confirmed real-life efficacy for patients with advanced non-squamous non-small cell lung cancer. With median progression-free survival and overall survival of 9.0 and 20.6 months, respectively and no new safety signal, our real-life data are very close to results provided by clinical trials, confirming the benefit and the manageable toxicity profile of this combination.
Background
Few therapeutic options are approved as second‐line treatment after failure of platinum‐based chemotherapy for patients with extensive‐stage small‐cell lung cancer (ES‐SCLC). Topotecan widespread use remains challenged by the risk of severe toxicities in a pretreated population. Little is known about the efficacy and safety of epirubicin–paclitaxel doublet in second‐line and beyond and especially cerebral outcomes.
Methods
EpiTax is a retrospective multicenter observational real‐life study. We evaluated the efficacy of epirubicin 90 mg/m
2
combined with paclitaxel 175 mg/m
2
every 3 weeks in SCLC patients after failure of at least one line of platinum‐based chemotherapy. The primary endpoint was progression‐free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), intracranial control rate (ICR), and safety.
Results
A total of 29 patients were included. The median of previous systemic therapy lines was 2 (1–4). Eleven patients received the treatment in the second line. Characteristics of patients were a median age of 60 years (45–77), 65.5% of males with 72.4% of PS 0–1. Fifteen patients had a history of brain metastases. Median PFS and OS achieved 11.0 (95% CI, 8.1–16.3) and 23 (95% CI, 14.1–29.6) weeks, respectively. ORR was 34.5% and DCR was 55.2%. ICR was 3/15 (20%). Grade 3–4 adverse events were mainly hematological and concerned 7 patients. No case of febrile neutropenia or toxic death was reported.
Conclusion
Epirubicin–paclitaxel association highlighted promising efficacy with
PFS
and
OS
of 11 and 23 weeks, respectively,
ORR
of 34.5%, and a tolerable safety profile. This doublet could represent another valuable therapeutic option for
ES‐SCLC
patients treated in the second line and beyond.
The prevalence of TSAT<20% was computed in two subgroups of patients receiving early treatment of the disease: either adjuvant or neo-adjuvant treatment.Results: A total of 443 patients with a documented curative treatment were analysed: 300 (67.7%) received an adjuvant treatment and 143 (32.3%) a neo-adjuvant treatment, consisting in chemotherapy in most cases. TSAT<20% was found in 47.1% (41.5-52.8) of patients with adjuvant treatment and 51.0% (42.9-59.1) of patients with neo-adjuvant treatment. Among iron-deficient patients according to ESMO definition (based on both ferritin level and TSAT), 85.8% and 90.1% of patients had a TSAT <20%, in the two treatment groups respectively.
Conclusions:The prevalence of ID in cancer patients receiving adjuvant or neoadjuvant treatment was high, and of the same magnitude than that reported in patients under metastatic treatment. Early diagnosis and treatment of ID in those patients at early-stage disease might limit the occurrence of anaemia and improve quality of life. TSAT < 20% as the sole criterion for defining ID had a high sensitivity and might be considered for ID diagnosis.Clinical trial identification: NCT03924271.Editorial acknowledgement: We thank Valérie Briand (IQVIA) for reviewing the abstract.Legal entity responsible for the study: Vifor Pharma Group.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.