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3. Clinical management of patients with thymic epithelial tumors: the recommendations endorsed by the Italian Association of Medical Oncology (AIOM)

Author

Conforti, F., Marino, M., Vitolo, V., Spaggiari, L., Mantegazza, R., Zucali, P., Ruffini, E., di Tommaso, L., Pelosi, G., Barberis, M., Petrini, I., Palmieri, G., Pasello, G., Galli, G., Berardi, R., Garassino, M., Filosso, P., Alloisio, M., Scorsetti, M., Orecchia, R., Pala, L., Abatedaga, L., Cinieri, S., and De Pas, T.

Published
2021
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4. Sex-based differences in response to anti-PD-1 or PD-L1 treatment in patients with non-small-cell lung cancer expressing high PD-L1 levels. A systematic review and meta-analysis of randomized clinical trials

Author

C. Corti, Chiara Catania, Giuseppe Giaccone, Paola Queirolo, Eleonora Pagan, Vincenzo Bagnardi, T. De Pas, Fabio Conforti, Laura Pala, Conforti, F, Pala, L, Pagan, E, Corti, C, Bagnardi, V, Queirolo, P, Catania, C, De Pas, T, and Giaccone, G

Subjects
Male, Oncology, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, immune checkpoint inhibitor, Review, NSCLC, B7-H1 Antigen, law.invention, immune checkpoint inhibitors, Randomized controlled trial, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, Clinical endpoint, Humans, Medicine, Prospective Studies, Lung cancer, Randomized Controlled Trials as Topic, Chemotherapy, business.industry, high PD-L1 expression, Hazard ratio, Immunotherapy, medicine.disease, Confidence interval, Meta-analysis, Female, business
Abstract

Background In our previous works, we demonstrated that patients’ sex affects the efficacy of immune checkpoint inhibitors (ICIs) in patients with several advanced solid tumors. Here, we assessed the sex-based heterogeneity of efficacy of anti-programmed cell death protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) given as monotherapy, for advanced non-small-cell lung cancer (NSCLC) expressing high PD-L1 levels, to evaluate if available evidence supports this therapeutic option for both women and men. Methods We carried out a systematic review and meta-analysis including all randomized, controlled trials testing anti-PD-1/anti-PD-L1 drugs in monotherapy, as first-line treatment of advanced NSCLC expressing high PD-L1 levels. The primary endpoint was the difference in efficacy of anti-PD-1/anti-PD-L1 drugs versus chemotherapy, between men and women, measured in terms of the difference in overall survival (OS) log [hazard ratio (HR)] reported in male and female study participants. Results We analyzed four randomized, controlled trials, including 1672 patients, of whom 1224 (73.2%) were men and 448 (26.8%) were women. The pooled OS-HR comparing anti-PD-1/anti-PD-L1 versus chemotherapy was 0.59 [95% confidence interval (CI), 0.50-0.69] for men and only 0.84 (95% CI, 0.64-1.10) for women. The pooled ratio of the OS-HRs reported in men versus women was 0.71 (95% CI, 0.52-0.98; P-heterogeneity: 0.04), indicating a significantly greater effect for men. No heterogeneity among single-study estimates was observed in either male patients (Q = 2.39, P = 0.50, I2 = 0%) or in female patients (Q = 1.13, P = 0.50, I2 = 0%). Conclusion Evidence available indicates anti-PD-1/anti-PD-L1 monotherapy as highly effective in men but not in women, even in NSCLCs expressing high PD-L1 levels. Prospective trials testing sex-based tailored immunotherapy strategies are needed., Highlights • Sex-based heterogeneity of efficacy of immune checkpoint inhibitors. • Sex-tailored immunotherapy strategies. • NSCLC expressing high PD-L1 levels.

Published
2021

5. TRAbectedin in adVanced rEtroperitoneal well differentiated/dedifferentiated Liposarcoma and Leiomyosarcoma (TRAVELL): results of a phase II study from the Italian Sarcoma Group.

Author

Fabbroni C, Grignani G, Vincenzi B, Fumagalli E, De Pas TM, Mazzocca A, Pantaleo MA, Brunello A, Baldi GG, Boglione A, Fatigoni S, Berruti A, Giordano M, Marrari A, Dei Tos AP, Alberton AS, Aliberti S, Carlucci L, Rulli E, Casali PG, and Sanfilippo R

Subjects
Humans, Male, Female, Middle Aged, Aged, Adult, Antineoplastic Agents, Alkylating therapeutic use, Antineoplastic Agents, Alkylating pharmacology, Italy, Aged, 80 and over, Leiomyosarcoma drug therapy, Trabectedin therapeutic use, Trabectedin pharmacology, Liposarcoma drug therapy, Retroperitoneal Neoplasms drug therapy
Abstract

Background: This is a multicentre, single-arm, phase II study aimed at further exploring the activity of trabectedin as second-/further-line treatment in retroperitoneal leiomyosarcoma (LMS) and well-differentiated/dedifferentiated liposarcoma (LPS)., Materials and Methods: The primary endpoint was the growth modulation index (GMI) defined as the ratio between PFS under trabectedin (PFS) and during previous chemotherapy treatment: time to progression (TTP-1). Secondary endpoints were objective response rate (ORR) and PFS. As per protocol, patients were considered responders if the GMI was >1.33, non-responders if <0.75 and neither if 0.76-1.32., Results: Overall 91 patients were assessable for the primary endpoint (32 patients with LMS and 59 patients with LPS): the median number of cycles received was 6.0 (Q1-Q3 3.0-12.0), and the main reason for treatment discontinuation was disease progression in 72% of patients. The median PFS was 6.0 months, while the median TTP1 was 7.5 months (8.1 and 6.4 months for LMS and LPS, respectively). Thirty-three patients [52%, 95% confidence interval (CI) 36% to 58%, P = 0.674, odds of response 1.1] had a GMI >1.33 (LMS 46%, 95% CI 26% to 67%, odds of response 0.85; LPS 56%, 95% CI 40% to 72%, odds of response 1.3). Overall, in LPS we observed 15/47 patients with a GMI <0.5 and 15/47 patients with a GMI >2. Among LMS patients, 9/26 had a GMI <0.5 and 10/26 had a GMI >2. Overall, ORR (complete response + partial response) was 16% (24% for LMS and 12% for LPS)., Conclusions: While the primary endpoint of the study was not met, we noticed a subgroup of patients with a markedly discrepant TTP with trabectedin in comparison to previous therapy (GMI <0.5 or >2, the latter including some patients with a long TTP with trabectedin). A mismatch between PFS and overall survival was observed, possibly due to the natural history of the two different histologies and the availability of further lines in LMS., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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