Abstract 3150
Background
The combination of cisplatin and pemetrexed is considered the standard of care front line regimen for malignant pleural mesothelioma (MPM). Several phase II trials demonstrated comparable response and survival rates with the use of gemcitabine and cisplatin. Few retrospective studies have compared the two regimens and with conflicting results. However, no prospective clinical trial has compared them directly.
Methods
Between June 2015 and September 2017, 51 chemotherapy-naïve MPM Pts were randomized 1:1 to receive either pemetrexed (500 mg/m2) and cisplatin (75mg/m2) (PC) or gemcitabine 1000 mg/m2 on days 1 and 8 combined with cisplatin (75 mg/m2) on day 1 (GC). Chemotherapy was repeated every 3 weeks for a maximum of six cycles unless there was earlier evidence of disease progression or unacceptable toxicity. We used modified RECIST criteria for mesothelioma to evaluate treatment response and CTCAE v4.0 to assess toxicity.
Results
The mean age was 52.5 years with males representing 51% of Pts. The ECOG PS was 0, I, and II in 3.9, 86.3, and 9.8% of cases, respectively. Epithelial histology was the most common (88.2%) followed by biphasic (9.8%) and sarcomatoid (2%). 6 pts had stage II disease, whereas 45 had stage III or IV. The baseline characteristics of the PC arm (N = 26) and GC arm (N = 25) were well-balanced in the age, gender, ECOG, pathology, and stage. RR with PC was 53.8% compared with 36% for GC (p value = 0.132). Significant superiorities in PFS and OS were observed with PC therapy. For the PC pts, the median PFS was 10.45 vs. 8.4 months for the GC Pts (log-rank p-Value < 0.001, HR = 3.23, CI (95%) = 1.693 − 6.175). The median OS was 16.15 months for the PC arm and 13.1 months for the GC arm (log-rank p-Value = 0.020, HR = 1.91, CI (95%) = 1.042 − 3.496). In general, hematological toxicities were more frequent in both arms in comparison to other types of toxicities. Neutropenia tended to be more severe with GC, whereas nausea was more frequent with PC. However, these differences in toxicity were statistically insignificant.
Conclusions
First-line treatment of MPM with PC resulted in statistically significant improvement in PFS and OS compared to GC, therefore it should remain the standard of care for this group of pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Ain Shams Faculty of Medicine IRB.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5344 - Global trends in population-based survival for 303,169 adults diagnosed with glioblastoma in 44 countries during 2000-2014 (CONCORD-3)
Presenter: Fabio Girardi
Session: Poster Display session 1
Resources:
Abstract
3088 - Spanish Survey of treatment recommendations for elderley patients with glioblastoma
Presenter: María Ángeles Vaz Salgado
Session: Poster Display session 1
Resources:
Abstract
3484 - Updated analysis of the National Registry of Nervous System Tumors in Spain (RETSINE). RETSINE: National Registry of Nervous System Tumors of the Spanish Research Group in Neuro-oncology (GEINO) and Spanish Infrequent and Orphan Tumors Group (GETHI)
Presenter: Isaac Ceballos Lenza
Session: Poster Display session 1
Resources:
Abstract
4737 - Development and validation of novel nomograms predicting survival of malignant ependymoma patients: A population-based study
Presenter: Alzhraa Abbas
Session: Poster Display session 1
Resources:
Abstract
4740 - Characteristics, incidence, and survival of primary cerebral lymphoma: A population based study
Presenter: Sherief Ghozy
Session: Poster Display session 1
Resources:
Abstract
5362 - Trends in Incidence and Survival Analyses of Adult-onset Medulloblastoma
Presenter: Feifei Lin
Session: Poster Display session 1
Resources:
Abstract
3868 - Meta of classical chemotherapy compared with high-dose chemotherapy combined with autologous stem cell transplantation in newly diagnosed medulloblastoma patients after radiotherapy
Presenter: Mengting Zhang
Session: Poster Display session 1
Resources:
Abstract
4446 - Effect of cumulative dose of maintenance temozolomide on overall survival in patients with high grade glia tumors: a single institution analysis
Presenter: Marta Nerone
Session: Poster Display session 1
Resources:
Abstract
5119 - Markers of systemic inflammation correlate with survival prognosis in patients with newly diagnosed brain metastases
Presenter: Angelika Starzer
Session: Poster Display session 1
Resources:
Abstract
3882 - Venous Thromboembolism and Intracranial Hemorrhage in Patients with High-grade Glioma
Presenter: Clara Borges
Session: Poster Display session 1
Resources:
Abstract