Citations

Clear

52 citation(s) found for "Khan, Muhammad Ali".

Stratified absolute benefit with adjuvant immunotherapy (aIO) in muscle-invasive bladder cancer (MIBC): A meta-analysis.
Naqvi, Syed Arsalan Ahmed , Saxena, Akshat , Faisal, Kunwer Sufyan , Bibi, Arifa, Cobran, Ewan K. , Khan, Muhammad Ali , Hussain, Syed A. , Riaz, Irbaz Bin , Bryce, Alan H. , Singh, Parminder Pal

Mayo Clinic

Journal of Clinical Oncology | June 6, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e16619-e16619

10.1200/jco.2024.42.16_suppl.e16619 Get It

e16619 Background: Should patients (pts) with MIBC receive aIO given the DFS benefit seen in AMBASSADOR and CheckMate 274 trials is an important clinical question. Thus, we aimed to quantify the magnitude of absolute benefit across different subgroups to aid clinicians in shared decision-making with their patients. Methods: Phase III trials evaluating aIO as compared to observation or placebo (obs/plac) in pts with MIBC were considered eligible. Outcomes of interest included DFS and OS. Pre-specified subgroups included disease location, PDL1 status, neoadjuvant chemotherapy (NAC) receipt, and tumor and nodal (TN) staging. Pairwise comparisons were made using a DerSimonian-Lairds (DL) random-effects meta-analysis. Stratified baseline risks (obtained from clinical trials) and relative effect estimates were used to estimate corresponding intervention risks (CIRs). The difference in CIRs and baseline risk was calculated to present absolute risk differences (ARDs) in each subgroup category. Results: Analysis included three trials with 2220 pts (pembrolizumab, nivolumab, and atezolizumab assessed in each). No significant difference was observed in OS with aIO compared to obs/plac (hazard ratio: 0.91; 0.76-1.09). However, aIO significantly improved DFS compared to obs/plac (0.76; 0.64-0.91) in the overall population. In pts with bladder/lower tract disease, aIO improved DFS compared to obs/plac (0.72; 0.56-0.92); however, no significant difference was observed in DFS in pts with upper tract disease. There was a statistically significant effect modification by disease location (p: 0.01). Adjuvant IO significantly improved DFS in PDL1- (0.78; 0.64-0.94) but not in PDL1+ pts (0.75; 0.52-1.08). Likewise, aIO significantly improved DFS in pts who received NAC (0.69; 0.53-0.90) but not in pts who did not receive NAC (0.89; 0.75-1.05). In terms of TN staging, aIO improved DFS in T2-3N0 (0.73; 0.57-0.94), T4N0 (0.76; 0.61-0.95), and in T2-4N1 patients (0.75; 0.59-0.95). No statistically significant modifications were observed among these subgroups. Stratified ARDs for DFS by each subgroup are outlined (Table). Conclusions: When delayed disease progression is a vital consideration, a risk-adapted strategy for the optimal patient selection to receive aIO should be considered. Disease location (lower tract/bladder), node positivity, and receipt of NAC emerged as groups likely to derive greater benefit with aIO. [Table: see text]
First-line (1L) systemic therapy in locally advanced/metastatic urothelial cancer (Ia/mUC): A living interactive systematic review and network meta-analysis.
Saxena, Akshat , Naqvi, Syed Arsalan Ahmed , Bibi, Arifa, Channar, Aneeta , Tripathi, Nikita , Raina, Ammad, Khakwani, Kaneez Zahra Rubab, Riaz, Irbaz Bin , Khan, Muhammad Ali , Childs, Daniel S. , Bryce, Alan H. , Singh, Parminder Pal

Mayo Clinic

Journal of Clinical Oncology | June 6, 2024 | Volume: 42 | Issue: 16_suppl | Pages: e16579-e16579

10.1200/jco.2024.42.16_suppl.e16579 Get It

e16579 Background: Recent results from EV 302 and CheckMate 901 have transformed the treatment landscape of untreated locally advanced/metastatic urothelial cancer (Ia/mUC). Here, we present the most up-to-date evidence of comparative efficacy and safety of first line (1L) treatment options in Ia/mUC with emphasis on Enfortumab vedotin (EV)-pembrolizumab (P) and gemcitabine (Gem)-cisplatin (Cis)-nivolumab (N). Methods: This living systematic review used the living interactive evidence (LIvE) synthesis framework. Full-text and abstract publications of phase II/III randomized clinical trials comparing 1L immunotherapy combined with chemotherapy (IO+C) or immunotherapy alone (IO) regimens with platinum-based chemotherapy (Plat) in Ia/mUC were included. Outcomes of interest included overall survival (OS), progression-free survival (PFS) and treatment-related grade 3 or greater adverse events (≥G3 TRAE). Mixed treatment comparisons were made using network meta-analysis. P-scores were computed to assess relative treatment rankings. Results: A total of 5 trials (8 references) with 4,749 patients and 9 unique treatments were included. EV-P and Gem-Cis-N were ranked first and second in terms of OS and PFS improvement. EV-P improved OS compared to Gem-Cis-N (HR: 0.60; 0.45-0.81), Gem-Plat-atezolizumab(A) (0.55; 0.42-0.72), durvalumab(D)- tremelimumab(T) (0.55; 0.42-0.72), Gem-Plat-P (0.55; 0.42-0.72), P (0.51; 0.39-0.68), D (0.47; 0.36-0.63), A (0.48; 0.36-0.63) and Gem-Plat (0.47; 0.38-0.58). EV-P also improved PFS compared to Gem-Cis-N (0.63; 0.48-0.82), Gem-Plat-A (0.55; 0.43-0.69), D-T (0.42; 0.33-0.53), Gem-Plat-P (0.58; 0.45-0.74), P (0.34; 0.26-0.44), D (0.35; 0.27-0.44) and Gem-Plat (0.45; 0.38- 0.54). For ≥G3 TRAE, A was ranked first with the lowest adverse events compared to others. EV-P (rank 5) had significantly fewer events compared to Gem-Plat, Gem-Plat-A, Gem-Cis-N and Gem-Plat-P. Gem-Cis-N was ranked last with significantly greater events compared to A, P, D, D-T, Gem-Plat, EV-P, and Gem-Plat-A (Table with ranks [p-scores]). Conclusions: Current evidence suggests that patients with untreated la/mUC experience improved survival and slower disease progression with EV-P when compared to other contemporary options. Gem-Cis-N may be a reasonable alternative in patients who are cisplatin-eligible. Cost and access to these treatments are crucial and should be considered to facilitate shared decision making. [Table: see text]
Secondary primary malignancies among patients with GU cancer.
Tripathi, Nikita , Ayaz, Ahsan , Naqvi, Syed Arsalan Ahmed , Saxena, Akshat , Bibi, Arifa, Channar, Aneeta , Tyson, Mark D. , Cobran, Ewan K. , Abdul‐Muhsin, Haidar , Khan, Muhammad Ali , Riaz, Irbaz Bin , Bryce, Alan H. , Singh, Parminder Pal

Mayo Clinic

Journal of Clinical Oncology | January 29, 2024 | Volume: 42 | Issue: 4_suppl | Pages: 98-98

10.1200/jco.2024.42.4_suppl.98 Get It

98 Background: The risk of secondary primary malignancies (SPM) among the survivors of GU cancer is not well-established. In this study, we attempt to describe the patterns of SPMs in patients diagnosed with GU cancers. Methods: The Surveillance, Epidemiology, and End Results (SEER) database (SEER*Stat 8.4.2) was searched to obtain data on the incidence of SPM in adult patients (age >18 years) diagnosed with GU cancers, including prostate, renal, and bladder cancer. Standardized incidence ratios (SIRs) with a 95% confidence interval (CI) were calculated. SIR was defined as the observed SPMS from each category divided by the expected number of SPMs in the age-matched US population for the same period. The data was further stratified by age (<50y, 50-70y, >70y), race (White, Black, Asian/Pacific Islander), ethnicity (Hispanic, non-Hispanic), chemotherapy, and radiotherapy exposure. Results: A total of 1,041,217 patients were included in this analysis. In patients diagnosed with GU cancer, the incidence of overall SPM was 11%. Particularly, patients with GU cancers were observed to have a high incidence of Endocrine system SPM (1.52; 1.45-1.59), and urinary system SPM (1.51; 1.49-1.53) These results were consistent by different sociodemographic groups. In patients diagnosed with prostate cancer, the incidence of thyroid SPM was increased (1.31; 1.23-1.39). Particularly, prostate cancer patients treated with radiation therapy had increased incidence rates of SPM in the peritoneum, omentum and mesentery (1.57; 0.79-2.81) and urinary bladder (1.36;1.32-1.40) was higher as compared to those with no exposure to radiation therapy (1.11;1.08-1.13 and 1.03;1-1.06 respectively). Bladder cancer patients had an overall increased incidence of SPM in the esophagus (1.21; 1.08-1.35), lung, bronchus, trachea, and other respiratory organs (1.97;1.92-2.01), prostate (3.50;3.4-3.6) and kidney (1.86;1.76-1.97). A higher incidence of renal pelvis, ureter and other urinary organ SPM (11.08;10.48-11.07) was also notable in this population. Similarly, kidney cancer patients had a higher incidence of the endocrine system (3.00;2.74-3.27), prostate (1.24;1.2-1.29) and bladder 1.78;1.68-1.79 SPMs. Conclusions: This population-based study shows an increased risk of SPM development in GU cancer survivors compared to the general population. Clinicians should keep a high index of suspicion for SPMs and initiate appropriate workups at early warning signs.
A cost-effectiveness analysis assessing systemic treatments in metastatic castration-sensitive prostate cancer (mCSPC) by volume of disease.
Naqvi, Syed Arsalan Ahmed , Faisal, Kunwer Sufyan , Khakwani, Kaneez Zahra Rubab, Houten, Holly K. Van , Sharma, Vidit , Boorjian, Stephen A. , Humphreys, Mitchell R. , Cobran, Ewan K. , Khan, Muhammad Ali , Moriarty, James P. , Borah, Bijan J. , Singh, Parminder Pal , Childs, Daniel S. , Sartor, Oliver , Riaz, Irbaz Bin , Bryce, Alan H.

Mayo Clinic

Journal of Clinical Oncology | January 29, 2024 | Volume: 42 | Issue: 4_suppl | Pages: 93-93

10.1200/jco.2024.42.4_suppl.93 Get It

93 Background: The treatment paradigm for mCSPC patients has rapidly evolved over the last few years with the emergence of triplet therapy and prognostication by volume of disease. However, the health economic implications of triplet therapy by disease volume remain unclear. Methods: A Markov model where patients transitioned between the progression-free, progression and death states was developed. State utilities were derived from the LATITUDE trial. Point probabilities for overall survival, progression-free survival, grade ≥ 3 and 5 toxicities were obtained from the eligible mCSPC phase III clinical trials. Medicare Advantage and commercial total paid amounts (2022 US$) of treatments were obtained from OptumLabs Data Warehouse. Costs and disutilities of adverse events were derived from published literature. Half-cycle corrected costs and utilities were accrued monthly over a 20-year lifetime horizon and were discounted at 3%. Monte Carlo simulation was used to calculate incremental cost-effectiveness ratios (ICERs). A willingness-to-pay (WTP) threshold of US$100,000 was used. Results: In terms of Medicare Advantage payer’s perspective (Table), docetaxel (D)+ADT was observed to provide additional 0.068 QALYs compared to ADT at an ICER of US$16,544 per QALY in high volume disease. Compared to D+ADT, abiraterone (AAP) triplet provided additional 1.03 QALYs at US$56,641 per QALY. Compared to AAP triplet, apalutamide (APA)+ADT provided additional 0.048 QALYs at US$5,846,248 per QALY in high volume disease. In low volume disease, D+ADT provided 0.45 more QALYs at US$20,690 per QALY compared to ADT alone. Compared to D+ADT, AAP triplet provided an additional 1.51 QALYS at US$44,267 per QALY. In terms of total paid commercial costs, AAP triplet provided an additional 1.19 QALYs compared to ADT at US$91,952 per QALY in high volume disease. In low volume, D+ADT provided additional 0.38 QALYs at US$22,058 per QALY compared to ADT. Compared to D+ADT, AAP triplet provided a 0.97 QALY gain at US$105,958 per QALY. Compared to AAP triplet, darolutamide (DARO) triplet provided a 0.47 QALY at US$689,196 per QALY. Compared to DARO triplet, APA+ADT provided an additional 0.49 QALYs at an ICER of US$971,389 per QALY. All other treatments (not reported here) were dominated. Conclusions: At the selected WTP of US$100,000 per QALY, AAP triplet therapy was most likely the cost-effective strategy in overall mCSPC population particularly in patients with high volume disease. However, these results should be interpreted with careful accounting for timing of metastases. [Table: see text]
Clinical efficacy of enfortumab-pembrolizumab combination therapy in locally advanced/metastatic urothelial carcinoma (UC): A real-world experience.
Tripathi, Nikita , Naqvi, Syed Arsalan Ahmed , Ballouz, Tara, Saxena, Akshat , Bibi, Arifa, Channar, Aneeta , Tyson, Mark D. , Ballouz, Tara, Khan, Muhammad Ali , Riaz, Irbaz Bin , Bryce, Alan H. , Singh, Parminder Pal

Mayo Clinic

Journal of Clinical Oncology | January 29, 2024 | Volume: 42 | Issue: 4_suppl | Pages: 643-643

10.1200/jco.2024.42.4_suppl.643 Get It

643 Background: The FDA approval of enfortumab (EV) and pembrolizumab (Pembro) combination therapy as a first-line treatment for cisplatin-ineligible patients with locally advanced/metastatic urothelial carcinoma (la/mUC) was based on the EV-103 trial. We aim to assess the clinical response rate of this combination therapy in our institution's patients with locally advanced and metastatic UC. Methods: This retrospective cohort study included 20 patients diagnosed with locally advanced/metastatic UC(la/mUC) who were treated with EV-Pembro combination for at least 2 cycles, from June 2022 to August 2023 at the Mayo Clinic. Patients who were treatment naïve or who progressed one or more lines of therapy were included in the study cohort. Main outcome of interest included imaging-based best overall response rate in terms of complete (CR) and partial (PR) response, stable disease (SD), and progressive disease (PD). Results: Out of 20 patients, the number of males and females were 16 (80%) and 4 (20%) respectively; the median age was 77 years (IQR: 51-92). 3 (15%) of patients had involvement of upper urinary tract disease along with bladder cancer. The common sites of visceral metastasis at the time of initial presentation include liver 2(10%), lung 6(30%) and lymph nodes12(60%). Common toxicities of this regimen included rash, pruritis, peripheral neuropathy, fatigue, transaminitis, dysgeusia, and diarrhea. The treatment was stopped in 10 (50%) patients due to completion of planned therapy (achieved CR or proceeded with resection of residual disease) (30%), 5 patients due to progression (50%), 1 patient due to therapy side effects (10%) and in 1 patient due to death (10%). The objective response was 45% (N =9); 5 (25%) had PR, and 4 (20%) had CR. A total of 2 (10%) had SD while 2 (10%) experienced PD. Histological correlation with clinical benefit is shown in the table. Conclusions: EV-Pembro combination therapy shows promising responses in patients who have progressed after previous lines of therapy, consistent with previously published data on EV 201 in small cohorts. However, ongoing expansion of this cohort and data from larger studies will help further elucidate survival benefits and their correlation with genetic testing. [Table: see text]
A meta-analysis assessing objective response rates with first-line systemic treatment options in locally advanced/metastatic urothelial carcinoma.
Saxena, Akshat , Naqvi, Syed Arsalan Ahmed , Tripathi, Nikita , Bibi, Arifa, Ballouz, Tara, Abdul-Muhsin, Haidar , Tyson, Mark D. , Khan, Muhammad Ali , Riaz, Irbaz Bin , Bryce, Alan H. , Singh, Parminder Pal

Mayo Clinic

Journal of Clinical Oncology | January 29, 2024 | Volume: 42 | Issue: 4_suppl | Pages: 639-639

10.1200/jco.2024.42.4_suppl.639 Get It

639 Background: Immunotherapy combined with chemotherapy (IO/C) as the first-line management of locally advanced or metastatic urothelial carcinoma (LA/mUC) has been investigated in multiple trials with conflicting outcomes. Therefore, we conducted a meta-analysis of available trials to compare objective response rates (ORR) of this combination regimen, both in overall and in cisplatin-ineligible populations. Methods: EMABSE and MEDLINE were searched from 2000 through July 20th, 2023, to identify phase II and III clinical trials assessing IO, C or both in LA/mUC. Main outcome of interest was objective response rates (ORR) as defined in the included trials. An inverse variance random-effects meta-analysis was performed to estimate pooled ORR using the restricted maximum likelihood estimation method. Subgroup differences were assessed among IO/C, IO alone, and C alone. The threshold for statistical significance was established at 0.1. Results: Of 5975 citations identified, a total of 26 trials with a total of 4,628 participants were included in this systematic review. In the overall group, the ORR in IO/C trials (5 trials, 1,236 patients) was 44.70% (95% CI: 21.88%- 70.0%). In IO trials (7 trials, 2,189 patients), ORR was 23.68% (19.55%- 28.36%) and in C trials (26 trials, 4,628 patients) was 43.46% (37.43%-49.68%]). In the cisplatin-ineligible group, the ORR in IO/C trials (2 trials, 240 patients) was 60.06% (33.38%-81.86%), in IO trials (6 trials, 1,103 patients) was 26.15% (23.01%; 29.56%), and in C trials (8 trials, 767 patients) was 42.45% (35.67%-49.52%). In terms of subgroup differences, the difference in ORR was statistically significant between IO/C and IO trials (p= 0.0844) and between IO and chemotherapy trials (p< 0.0001) in the overall population. Similarly, we found a statistically significant difference in ORR between IO/C and IO (p= 0.0108) and between IO and chemotherapy trials (p< 0.0001) in the cisplatin-ineligible population. No statistically significant differences were observed between IO/C and C alone. Conclusions: First-line IO/C may achieve a better objective response compared to IO alone in patients diagnosed with locally advanced/metastatic UC. Although, there appears to be a trend of greater benefit with IO/C compared to C alone, the difference was not statistically significant. The results will be updated as soon data from new trials (CheckMate 901 and EV 302) becomes available which could offer new insights. [Table: see text]
First-line PARP inhibitors (PARPi) with androgen receptor pathway inhibitors (ARPi) in metastatic castration-resistant prostate cancer (mCRPC): A systematic review and meta-analysis.
Naqvi, Syed Arsalan Ahmed , Imran, Manal , Channar, Aneeta , Saxena, Akshat , Raina, Ammad, Khakwani, Kaneez Zahra Rubab, Riaz, Zaryab Bin, Kase, Adam M. , Humphreys, Mitchell R. , Moore, Cassandra N., Orme, Jacob J. , Palmer, Jeanne , Khan, Muhammad Ali , Childs, Daniel S. , Singh, Parminder Pal , Bryce, Alan H. , Riaz, Irbaz Bin

Mayo Clinic

Journal of Clinical Oncology | January 29, 2024 | Volume: 42 | Issue: 4_suppl | Pages: 173-173

10.1200/jco.2024.42.4_suppl.173 Get It

173 Background: The data for combining PARPi and ARPi in mCRPC have shown conflicting results. Here, we report a quantitative summary of benefits by clinically meaningful subgroups (HRR mutation status, BRCA mutation status) to guide the use of PARPi and ARPi combination in mCRPC setting. Methods: MEDLINE, EMBASE, and CENTRAL were systematically searched from each database’s inception through September 7, 2023. Phase III studies comparing PARPi + ARPi with ARPi + placebo in mCRPC were included. Radiographic progression-free survival (rPFS) and overall survival (OS) in patient subgroups based on HRR and BRCA mutation status were assessed. Hazard ratios for rPFS and OS with 95% CI were collected at the level of each trial, and a random-effects meta-analysis was conducted using an inverse variance approach. Subgroup differences were assessed and p-value of interaction <0.1 was considered statistically significant. Results: The literature search identified 4976 studies from which 3 trials (11 references) – TALAPRO2, PROpel and MAGNITUDE met the inclusion criteria. A total of 2254 participants were eligible for analysis. PARPi + ARPi prolonged rPFS in patients with HRR mutations (HR: 0.55, 95%CI: 0.38-0.78) as well as in patients without HRR mutations (HR: 0.74, 95%CI: 0.63-0.88). There is no evidence of treatment interaction by HRR mutation status (p = 0.14). In patients harboring HRR mutations, improved rPFS was observed in those with BRCA mutations (HR: 0.28, 95%CI: 0.13-0.62) as well as those without BRCA mutations (HR: 0.72, 95%CI: 0.59-0.87). However, there is evidence that patients with BRCA mutations derived greater rPFS benefit as compared to patients without BRCA mutations (p =0.02). PARPi + ARPi showed no significant improvement in overall survival either in patients with HRR mutations (HR: 0.79, 95%CI: 0.59-1.05) or in patients without HRR mutations (HR: 0.92, 95%CI: 0.74-1.14). Conclusions: Genomic testing for HRR genes is mandatory to guide clinical decision making in mCRPC patients. Patients harboring BRCA mutations are most likely to derive clinically meaningful benefit from combination PARPi + ARPi treatment. [Table: see text]
Toxicity Profile of Janus Kinase Inhibitors (JAKi) in Patients with Myelofibrosis: A Report from a Living Systematic Review and Meta-Analysis
Naqvi, Syed Arsalan Ahmed , Saeed, Shahzeb , Faridi, Shanza, Khakwani, Kaneez Zahra Rubab, Palmer, Jeanne , Khan, Muhammad Ali , Riaz, Irbaz Bin

Mayo Clinic

Blood | December 1, 2023 | Volume: 142 | Issue: Supplement 1 | Pages: 6433-6433

10.1182/blood-2023-188107 Get It

Background Janus kinase inhibitors are actively investigated for treating various hematological, rheumatological, gastrointestinal and dermatological indications. Thus, we have initiated a living systematic review to define the toxicity profile of JAKi agents. Here, we report an up-to-date assessment of toxicity profile of JAKi in patients with myelofibrosis. Methods MEDLINE, EMBASE and CENTRAL were systematically searched from each database's inception through June 13, 2023, to identify phase I/II/III clinical trials assessing JAKi in myelofibrosis reporting adverse events. The main outcomes of interest included incidence rates of all-cause and treatment-related grade ≥ 3, grade 5 and all-grade AEs of interest (infections, hematological, gastrointestinal, and cardiovascular adverse events). Incidence rates (incidence per 100-person-years) for AEs of interest were calculated at the level of each trial. A random-effects meta-analysis was conducted to pool the incidence rates of AEs using an inverse-variance approach. Results The literature search identified 2044 studies from which 28 clinical trials (33 references) met the inclusion criteria - 4 (14%) trials were phase I, 4 (14%) trials were phase I/II, 13 (46%) trials were phase II, and 7 (25%) trials were phase III. A total of 4505 participants received JAKi and were eligible for analysis. All-cause and treatment-related hematological toxicities were reported in 28 (100%) and 18 (64%) trials, all-cause and treatment-related gastrointestinal toxicities were reported in 28 (100%) and 18 (64%) trials, all-cause and treatment-related cardiovascular toxicities were reported in 20 (71%) and 12 (43%) trials whereas all-cause and treatment-related infections were reported in 26 (93%) and 14 (50%) trials, respectively. The incidence rate per 100-person years for all-cause and treatment related adverse events of interest are summarized in Table 1a and 1b respectively. For treatment-related AEs, the incidence of grade ≥ 3 diarrhea with JAKi is 8.50 (95% CI: 5.34-13.53) events per 100-person years. The incidence of treatment-related grade ≥ 3 anemia and thrombocytopenia is 39.40 (95% CI: 25.57-60.71) and 29.25 (95% CI: 20.12-42.51) events per 100-person years respectively. The incidence of treatment-related grade 5 diarrhea with JAKi is 2.15 (95% CI: 1.07-4.29) events per 100-person years whereas the incidence of treatment-related grade 5 anemia and thrombocytopenia is 2.03 (95% CI: 1.04-3.97) and 2.01 (95% CI: 1.02-3.93) events per 100-person years respectively. For all-cause AEs, the incidence of grade ≥ 3 nausea, vomiting and diarrhea with JAKi is 1.72 (95% CI: 0.97-3.05), 3.56 (95% CI: 1.92-6.61) and 5.29 (95% CI: 3.48-8.04) events per 100-person years respectively. The incidence of all-cause grade ≥ 3 infections with JAKi is 4.38 (95% CI: 1.95-9.83) events per 100-person years whereas the incidence of all-cause grade ≥ 3 respiratory tract infections with JAKi is 4.21 (95% CI: 2.41-7.36) events per 100-person years. The incidence of all-cause grade ≥ 3 anemia, neutrophil decrease and thrombocytopenia is 46.83 (95% CI: 32.68-67.11), 29.11 (95% CI: 14.86-57.02) and 34.39 (95% CI: 23.82-49.64) events per 100-person years respectively. Moreover, the incidence of all-cause grade 5 nausea, vomiting and diarrhea with JAKi is 1.25 (95% CI: 0.72-2.18), 2.01 (95% CI: 1.08-3.74) and 1.60 (95% CI: 0.94-2.72) events per 100-person years respectively. In addition, the incidence of all-cause grade 5 infections and infestations is 3.71 (95% CI: 1.96-7.04) events per 100-person years with the incidence of grade 5 respiratory tract infections being 1.66 (95%CI: 0.89-3.10) events per 100-person years. Furthermore, the incidence of all-cause grade 5 anemia, neutrophil decrease and thrombocytopenia is 2.10 (95% CI: 1.26-3.52), 3.00 (95% CI: 1.25-7.21) and 1.95 (95% CI: 1.15-3.33) events per 100-person years respectively. Conclusions This report of living systematic review provides the best current evidence on toxicity profile of JAKi in patients with myelofibrosis. Current evidence suggests an overall higher incidence of all grade and grade ≥ 3 treatment related gastrointestinal adverse events in patients receiving JAKi. This living review will be updated as soon as new data becomes available.
Patient Cost Savings When Using Telehealth for Management of Myeloproliferative Neoplasms
Khan, Muhammad Ali , Naqvi, Syed Arsalan Ahmed , Yi, Cecilia Y. Arana , Camoriano, John , Padrnos, Leslie , Blocher, Joshua, Palmer, Jeanne , Yi, Cecilia Arana , Andres, Jennifer , Riaz, Irbaz Bin

Mayo Clinic

Blood | December 1, 2023 | Volume: 142 | Issue: Supplement 1 | Pages: 6409-6409

10.1182/blood-2023-187931 Get It

Introduction: Telemedicine has been widely utilized in the healthcare marketplace since the beginning of the COVID-19 pandemic. Over the last 3 years, virtual care has been widely employed in the care of patients with polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF) at Mayo Clinic. These rare disorders have few experts; therefore, telemedicine becomes an optimal approach for patients receive expert care even when they are not close to the medical center. 1 Additionally, telemedicine reduces financial burden for the patients. We aim to estimate potential cost savings to patients utilizing telemedicine. Methods: We identified patients with MPN seen at Mayo Clinic, Arizona who have had at least 2 visits (1 or more virtual visits) between March 2020 and June 2022. We extracted retrospective data from electronic medical records (EMR) including sociodemographic data, disease related data and number of visits - both virtual and in person - of the patients identified. The address recorded from the EMR was assumed to be the patient's location at the time of virtual visit. Driving distances were determined using zip codes in Google Maps and the patients were stratified into quartiles based on round trip travel distances. Patients in quartiles 1 through 3 were assumed to have driven while patients in quartile 4 were assumed to have traveled by plane. Patients in quartile 1 were assumed to have 1 travel day including the follow-up visit and no accommodation, patients in quartile 2 were assumed to have 2 travel days including the follow up visit and 1 night of accommodation whereas patients in quartiles 3 and 4 were assumed to have 2 travel days, 1 day for the follow up visit and 2 nights of accommodation. Mileage rate costs were based on US Internal Revenue Service (IRS) standard mileage rates for medical or moving purposes for 2021. 2 Owing to extreme variability in flight costs, flying costs were assumed to be equal to the driving costs. Per diem costs for accommodation and meals and incidentals were based on the US General Services Administration (GSA) 2021 rates for Phoenix 3 with the cost being 75% of the full per diem rate on traveling days via GSA formulaic approach. Results: One hundred and eight patients having 282 virtual visits were identified. Patients ranged from 30 - 87 years with the mean and median age of 65 years and 67 years respectively. Majority of the patients were female (62%) and white (98%) with gender distribution varying by distance. Descriptive statistics of the estimated out-of-pocket costs for patients by distance quartiles are summarized in Table 1a. Mean estimated cost savings ranged from $46.8 to $877.3 with the savings of $43.8 - $1372.2 at extremes. The total cost savings by all patients was $90,306.7. The breakdown of costs by category for each quartile is shown in Table 1b which shows that the majority of costs saved by patients in quartile 1 were due to avoiding costs spent on meals and incidentals (~90% of mean costs) whereas costs saved due to meals and incidentals for patients in quartile 4 were only ~16% of the mean costs. Conclusions: Our research highlighted telemedicine as a cost-effective approach for patients with MPN who received virtual care from March 2020 - June 2022. Study limitations included not weighing costs for childcare or accompanying individuals and using driving costs instead of flying costs, however, these considerations potentially underestimate the actual cost savings to the patient. Additionally, since the median age of this population was 65, we didn't include loss of wages to the analysis, which may further underestimate the costs. Despite concerns over billing, reimbursement, and state licensure, virtual care is being established as a critical part of medicine moving forward. 1. Doolittle, G.C. and A.O. Spaulding, Providing Access to Oncology Care for Rural Patients via Telemedicine. Journal of Oncology Practice, 2006. 2(5): p. 228-230. 2. Internal Revenue Service. Standard mileage rates for 2021. Available at: https://www.irs.gov/tax-professionals/standard-mileage-rates 3. US General Services Administration. Per diem rates. Available at: https://www.gsa.gov/travel/plan-book/per-diem-rates/per-diem-rates-results?action=perdiems_report&fiscal_year=2021&state=AZ&city=&zip=85054
Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia
Badar, Talha , Dinner, Shira, Liedtke, Michaela , Shallis, Rory M. , Yurkiewicz, Ilana R. , Kuo, Eric , Yang, Jay , Patel, Anand , Curran, Emily , Wang, Amy , Arslan, Shukaib , Siebenaller, Caitlin, Mattison, Ryan J. , Litzow, Mark R. , Wadleigh, Martha , Hefazi, Mehrdad , Podoltsev, Nikolai , Patel, Anand , Badar, Talha , Szabó, Anikó , Burkart, Madelyn , Khan, Muhammad Ali , Balasubramanian, Suresh , Hefazi, Mehrdad , Aldoss, Ibrahim , Advani, Anjali S. , Atallah, Ehab

Mayo Clinic

Cancer | December 1, 2020 | Volume: 127 | Issue: 7 | Pages: 1039-1048

10.1002/cncr.33340 | PMID 33259056 Get It

BackgroundThe availability of novel agents (NAs), including blinatumomab and inotuzumab ozogamicin (InO), has improved the outcomes of patients with relapsed/refractory (RR) B‐cell acute lymphoblastic leukemia (ALL). Because of the relative effectiveness, it is often a challenge for clinicians to determine how to best sequence these NAs with respect to efficacy and toxicity.MethodsIn this multicenter, retrospective study of patients with RR ALL treated with blinatumomab, InO, or both, their efficacy as a first or second NA was compared.ResultsAmong 276 patients, 221 and 55 received blinatumomab and InO, respectively, as a first NA therapy. The complete remission (CR)/complete remission with incomplete count recovery (CRi) rate was 65% and 67% for the blinatumomab and InO groups, respectively (P = .73). The rate of treatment discontinuation due to adverse events was 4% and 7% in the blinatumomab and InO groups, respectively. Ninety‐two patients (43%) in the blinatumomab group and 13 patients (29%) in the InO group proceeded with allogeneic hematopoietic stem cell transplantation. The median overall survival (OS) was 15 and 11.6 months in the blinatumomab and InO groups, respectively. A subset analysis was performed for 61 patients who received both NAs (blinatumomab and then InO [n = 40] or InO and then blinatumomab [n = 21]). The CR/CRi rate was 58% for patients who received InO as the second NA and 52% for patients who received blinatumomab as the second NA. The median OS was 10.5 for patients who received InO as the second NA and 5.9 months for patients who received blinatumomab as the second NA (P = .09).ConclusionsAlthough the limited power of this study to detect a significant difference between subgroups is acknowledged, the data suggest that blinatumomab and InO may have comparable efficacy as a first or second NA therapy in RR ALL.