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.
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