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
5995 - Invasive fungal diseases caused by rare pathogens in patients after hematopoietic stem cell transplantation (HSCT) & chemotherapy
Presenter: Yuliya Rogacheva
Session: Poster Display session 1
Resources:
Abstract
2961 - Safety and pharmacokinetics of novel CXCR4 antagonist YF-H-2015005 in the mobilization of hematopoietic stem cells in patients with non-Hodgkin's lymphoma
Presenter: Weiping Liu
Session: Poster Display session 1
Resources:
Abstract
5771 - Chemotherapy associated Hyponatremia in Hematological Malignancies: A retrospective study of 189 patients treated in a single medical center
Presenter: Vadim Lesan
Session: Poster Display session 1
Resources:
Abstract
1165 - Risk factors for Bacteremia-Associated Mortality of Aeromona sobria in Hematologic Malignancies
Presenter: Gabriel De la Cruz-Kú
Session: Poster Display session 1
Resources:
Abstract
5287 - Use of droplet digital polymerase chain reaction for detecting minimal residual disease: a prospective, multi-institutional study
Presenter: Hyunkyung Park
Session: Poster Display session 1
Resources:
Abstract
1886 - RUBIH2 — Use of NGS in haematological malignancies: from real world data to national recommendations, an innovative program to evaluate the impact of healthcare technology on patient care
Presenter: Severine Coquerelle
Session: Poster Display session 1
Resources:
Abstract
1940 - Outcomes of chronic myeloid leukemia with T315I mutation in the absence of targeted therapy or hematopoietic stem cell transplantation
Presenter: Nageswara Palukuri
Session: Poster Display session 1
Resources:
Abstract
1946 - Is bone marrow examination indispensible in chronic myeloid Leukemia at diagnosis ?
Presenter: Nageswara Palukuri
Session: Poster Display session 1
Resources:
Abstract
1904 - Incidence of Imatinib Resistance in Chronic Myeloid Leukemia (CML) Patients: Experience from Resource Poor Centre of Eastern India
Presenter: Debmalya Bhattacharyya
Session: Poster Display session 1
Resources:
Abstract
3245 - BCR-ABL transcript variant’s significance in chronic myeloid leukemia in chronic phase: Institutional experience from a developing country
Presenter: Siva Prasad
Session: Poster Display session 1
Resources:
Abstract