Aim: To compare the overall survival (OS) among patients who received first-line modified gemcitabine plus nab-paclitaxel (G/nab-P) or 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFOLFIRINOX) for metastatic pancreatic cancer. Methods: A single-center, retrospective, real-world study was conducted. Results: The median OS was 9.4 months versus 7.5 months in the mFOLFIRINOX and modified G/Nab-P groups, respectively (p = 0.16). An exploratory subgroup analysis excluding patients who received one infusion and had an Eastern Cooperative Oncology Group performance score of 2 demonstrated similar OS of 11.3 months and 8.9 months, respectively. Median progression-free survival and time-to-treatment failure were not significantly different. Higher rates of adverse events were noted with mFOLFIRINOX. Conclusion: mFOLFIRINOX did not significantly prolong OS compared with modified G/nab-P and was associated with increased toxicities.
Background
Primary central nervous system lymphoma (PCNSL) is a rare malignancy with few treatment options. One regimen used for induction is rituximab, high-dose methotrexate (HD-MTX), procarbazine, and vincristine (R-MPV). A common institutional practice is removing vincristine (VCR) from this regimen due to its poor CNS penetration and associated toxicities. The aim of this study was to evaluate how the omission of VCR from HD-MTX-based induction impacted clinical outcomes.
Methods
In a retrospective review, patients with PCNSL who received HD-MTX-based induction therapy between January 1, 2010 and May 31, 2018 were evaluated. Patients were stratified according to treatment into 2 groups, VCR-containing therapy versus no VCR. The primary endpoint was complete response (CR) rate following the completion of induction chemotherapy. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse event rate.
Results
Twenty-nine patients were included: 16 patients in the VCR group and 13 in the non-VCR group. A CR was achieved in 7 (44%) and 5 (38%) (odds ratio [OR] = 1.24; 95% confidence interval [CI]: 0.28–5.53) patients, respectively. Median OS was 85.3 (95% CI: 20.2–85.3) versus 67.1 months (95% CI: 10.5–NR) and median PFS was 60.7 (95% CI: 9.4–NR) versus 23.7 months (95% CI: 4.7–NR) in the VCR group versus non-VCR group, respectively. The incidence of any grade peripheral neuropathy was higher in the VCR group.
Conclusions
CR rate, OS, and PFS were similar between groups regardless of VCR inclusion. Adverse events were higher in the VCR group. Larger studies are required to further evaluate the efficacy of VCR in PCNSL induction regimens.
Background: Venetoclax (VEN) in combination with hypomethylating agent (HMA) therapy is a standard treatment option for patients with newly diagnosed acute myeloid leukemia (AML); however, data are limited in the relapsed or refractory (R/R) populations and in those with poor-risk disease. A retrospective review was conducted involving patients with AML who received HMA alone or in combination with VEN (VEN + HMA).Methods: VEN + HMA was compared to HMA alone in first-line and R/R settings. Patients were stratified by specific HMA and line of therapy. The primary endpoint was overall response rate (ORR) up to 6 months from start of treatment.Results: Fifty-two patients were evaluated for efficacy and 78 patients for safety. ORR was 67% (VEN + HMA) versus 80% (HMA) in the first line and 50% versus 22% in R/R setting. A greater clinical benefit was seen with VEN + HMA compared to HMA in both lines of therapy (first-line: 87% vs. 80%; R/R: 75% vs. 67%). The median duration of response was longer with VEN + HMA first-line, but shorter in the R/R setting compared to HMA (8.3 vs. 7.2 months and 2.5 vs. 3.7 months, respectively). Of the 32 patients who responded to therapy, 63% had a complex karyotype. Survival benefits were greater with VEN + HMA in both lines of therapy, although not statistically significant. Grade 3/4 neutropenia was reported in all patients receiving VEN, and 95% of these patients also experienced grade 3/4 thrombocytopenia. There were three cases of tumor lysis syndrome.
Conclusion:The addition of VEN to HMA has consistently shown benefit as first-line treatment and may have some benefit in R/R settings as well. Further studies are needed to compare across various lines of treatment and unfavorable disease. Dynamic strategies that improve toxicity management should be considered.
OBJECTIVES
1) Determine the response rate (RR) after chemotherapy with high-dose methotrexate with or without vincristine in patients with primary CNS lymphoma. 2) Determine the difference in adverse effects with the use of vincristine. 3) Determine the difference in progression-free survival (PFS) and overall survival (OS) between the 2 groups.
METHODS
Retrospective study in patients 18–89 years with primary CNS lymphoma that received chemotherapy with rituximab (R), methotrexate (M), procarbazine (P), and vincristine (V) R-MPV, R-MV, R-MP, or R-M between 2010 and 2018 at The Ohio State University. Response rate by cycle 7 was compared with odds ratio. Kaplan-Meier curves were used to compare OS and PFS.
RESULTS
29 patients were included: 16 (55%) received vincristine. 14/16 patients treated with vincristine and 4/13 in the other group also had procarbazine. 12/29 patients had a complete response after a maximum of 7 cycles. The odds of complete response were 24% higher in patients treated with vincristine but the difference did not reach statistical significance. Side effects were higher in the vincristine arm. The most common was peripheral neuropathy (75% vs 8% - all grades). Median PFS was 60.7 months for the vincristine group and 23.7 months for the non-vincristine group. Median OS was 85.3 months for the vincristine group and 67.1 months for the non-vincristine group. OS and PFS curves did not differ significantly.
CONCLUSIONS
The use of vincristine in high-dose methotrexate chemotherapy regimens for CNS lymphoma was not associated with a statistically significant difference in RR. Patients who received vincristine had more side effects and there were no significant differences in OS and PFS. The sample size and rate of procarbazine use may be confounding factors. Further studies are necessary to determine the effect of vincristine in RR and OS in these patients.
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