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Articles by F. Barlesi
Targeting KRAS in non-small cell lung cancer: recent progress and new approaches
Highlights • Better understanding of RAS signaling has led to development of promising directly blocking compounds in KRAS mutant tumors • New drug candidates take advantage of the increased knowledge of KRAS mutation complex and relevant protein structures • Increasing evidence continues to demonstrate the genomic heterogeneity in KRAS-mutated NSCLC • Current efforts include understanding and overcoming resistance after treatment with KRASG12C inhibitors Abstract Rat sarcoma (RAS) is the...
Retrospective study of hypersensitivity reactions to chemotherapeutic agents in a thoracic oncology service
What is known and objective With the increasing use of cancer chemotherapy agents, hypersensitivity reactions are commonly encountered. The allergic clinical symptoms are variable and unpredictable. The aim of this study was to identify the characteristics of hypersensitivity reactions and to assess the value of skin tests for platinum salts and pemetrexed in the treatment of patients with non-small cell lung cancers or malignant pleural mesothelioma.
438O Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC
Background: Atezolizumab (atezo) inhibits the binding of PD-L1 to its receptors PD-1 and B7.1, thereby restoring tumor-specific T-cell immunity, while leaving the PD-L2/PD-1 interaction intact. Atezo demonstrated survival benefit vs docetaxel (doc) in the Ph2 trial POPLAR. Here we present the primary analysis from the Ph3 OAK study evaluating atezo vs doc in previously treated NSCLC.
Observational data on the clinical benefit of epoetin beta in cancer patients with anemia
Background: Anemia is a frequent complication of chemotherapy that can reduce quality of life as well as the anti-cancer efficacy of treatment. Methods: Two prospective observational studies have investigated, in a real-life setting, the efficacy and safety of epoetin beta in treatment of chemotherapy-induced anemia.
Phase II study of roniciclib in combination with cisplatin/etoposide or carboplatin/etoposide as first-line therapy in subjects with extensive-disease small cell lung cancer (ED-SCLC)
Background: Patients with ED-SCLC have a poor prognosis. We conducted a phase II study to evaluate the efficacy and safety of roniciclib (R), an oral pan-cyclin-dependent kinase inhibitor, in combination with standard first-line platinum-based chemotherapy in subjects with ED-SCLC (NCT02161419).
IFCT-1003 LADIE trial: Randomized phase II trial evaluating treatment with EGFR-TKI versus EGFR-TKI associated with anti-estrogen in women with non-squamous advanced stage NSCLC
Background: The incidence of lung cancer is increasing dramatically in women and displays some specific epidemiological, radiological, clinical and pathological characteristics. Two main mechanisms emerged from recent findings in the field of lung carcinogenesis in women: the preferential involvement of the EGFR pathway and the potential impact of hormonal factors. The interaction of estrogen receptors with growth factor receptor signalling has also been shown.
Phase 1b expansion cohort study to evaluate the safety and efficacy of necitumumab and abemaciclib combination therapy in patients with stage IV non-small cell lung cancer (NSCLC)
Background: Trials of anti-EGFR necitumumab (neci) and the CDK4 and CDK6 inhibitor abemaciclib have demonstrated anti-tumor activity of each agent in patients with NSCLC. Trial design: Single-arm, multicenter Phase 1b expansion cohort study to investigate the effectiveness, safety and tolerability of neci combined with abemaciclib in ?70 patients with Stage IV NSCLC (NCT02411591).
Updated efficacy and safety from the global phase II NP28673 study of alectinib in patients (pts) with previously treated ALK+ non-small-cell lung cancer (NSCLC)
Background: Alectinib is an FDA-approved ALK inhibitor for pts with ALK+ NSCLC, who have progressed on, or are intolerant to, crizotinib. Alectinib has shown systemic and CNS activity in previously treated pts in two pivotal phase II trials (NCT01801111 [NP28673] and NCT01871805 [NP28761]). We report updated safety and efficacy (data cut-off 01 Feb 2016) from the global NP28673 study (previously at ECC 2015 [Barlesi et al]).
Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC
Background: In the randomized phase 2/3 KEYNOTE-010 study (NCT01905657), pembrolizumab significantly prolonged OS compared with docetaxel in previously treated, PD-L1–positive (tumor proportion score [TPS] ?1% and ?50%), advanced NSCLC. Here, we report HRQoL findings from KEYNOTE-010. Methods: Patients (pts) with PD-L1–positive NSCLC who progressed after platinum-based chemotherapy were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg Q3W or docetaxel 75 mg/kg.
Long-term outcomes with nivolumab (Nivo) vs docetaxel (Doc) in patients (Pts) with advanced (Adv) NSCLC: CheckMate 017 and CheckMate 057 2-y update
Background: The phase III trials CheckMate 017 (NCT01642004) and CheckMate 057 (NCT01673867) demonstrated improved OS with the anti-programmed death (PD)-1 antibody nivo vs doc as treatment (tx) for adv previously treated squamous (SQ) and non-SQ (NSQ) NSCLC, respectively. Approval of nivo in these indications was based on results of these studies. Updated results based on a minimum follow-up (f/u) of 2 y are reported.
Phase I, safety, tolerability and preliminary efficacy study of tremelimumab (Trem) in combination with gefitinib (Gef) in EGFR-mutant (EGFR-mut) NSCLC (GEFTREM)
Background: A Phase I open-label multicenter study was initiated to evaluate the association of T-cell lymphocyte-4 (CTLA-4) inhibitor Trem with Gef in progressing EGFR-mut NSCLC (NCT02040064). Methods: Key inclusion criteria included advanced NSCLC with an EGFR-mut, progression after a response on any prior EGFR TKI (first line or beyond), adequate PS (0-1).
Time to response in patients with ALK+ NSCLC receiving alectinib in the phase II NP28673 and NP28761 studies
Background: Alectinib was approved by the FDA based on the efficacy and safety shown in two phase II studies (NP28673 [NCT01801111] and NP28761 [NCT01871805]) of patients (pts) with previously treated ALK+ non-small-cell lung cancer (NSCLC). Both studies showed that alectinib achieved high response rates (51% and 52%, respectively) and that responses were durable (median 14.1 mos and 13.5 mos, respectively) (Barlesi et al, ECC 2015; Shaw et al, WCLC 2015).
Selumetinib in combination with docetaxel as second-line treatment for patients with KRAS-mutant advanced NSCLC: Results from the phase III SELECT-1 trial
Background: KRAS-mutant (KRASm) NSCLC is the largest molecular genomic NSCLC subset. Selumetinib (SEL; AZD6244, ARRY-142886) is an oral, potent and selective MEK1/2 inhibitor with a short half-life. In a Phase II KRASm advanced NSCLC trial (n = 87), 2L SEL + docetaxel (DOC) significantly improved PFS (median 5.3 vs 2.1 mo) and ORR (37 vs 0%), and numerically improved OS (median 9.4 vs 5.2 mo; primary endpoint) compared with DOC.
Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC
Background: Atezolizumab (atezo) inhibits the binding of PD-L1 to its receptors PD-1 and B7.1, thereby restoring tumor-specific T-cell immunity, while leaving the PD-L2/PD-1 interaction intact. Atezo demonstrated survival benefit vs docetaxel (doc) in the Ph2 trial POPLAR. Here we present the primary analysis from the Ph3 OAK study evaluating atezo vs doc in previously treated NSCLC.
Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Primary lung cancer remains the most common malignancy after non-melanocytic skin cancer, and deaths from lung cancer exceed those from any other malignancy worldwide [1]. In 2012, lung cancer was the most frequently diagnosed cancer and the leading cause of cancer death in male populations. Among females, lung cancer was the leading cause of cancer death in more developed countries, and the second leading cause of cancer death in less developed countries [2].
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