A Multicenter Real-World Study of Outcomes in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with a Polatuzumab Vedotin-Based Regimen in a Compassionate Use Program in Malaysia
Corresponding Author
S. Fadilah Abdul Wahid
Pusat Terapi Sel (PTS), Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM UKM), Kuala Lumpur, Malaysia
Search for more papers by this authorNor Asiah Muhamad
Sector for Evidence-based Healthcare, National Institutes of Health, Ministry of Health Malaysia, Putrajaya, Malaysia
Search for more papers by this authorNor Azimah Ismail
Pusat Terapi Sel (PTS), Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM UKM), Kuala Lumpur, Malaysia
Search for more papers by this authorIzzah Athirah Rosli
Sector for Evidence-based Healthcare, National Institutes of Health, Ministry of Health Malaysia, Putrajaya, Malaysia
Search for more papers by this authorChiang Su Kien
Department of Medicine, Haematology Unit, Hospital Pulau Pinang, Penang, Malaysia
Search for more papers by this authorSoo Min Lim
Department of Haematology, Hospital Sultanah Aminah, Johor Bahru, Johor, Malaysia
Search for more papers by this authorLee Ping Chew
Haematology Unit, Medical Department, Sarawak General Hospital, Kuching, Sarawak, Malaysia
Search for more papers by this authorKirubamoorthy Kamini
Hospital Raja Permaisuri Bainun, Ipoh, Perak, Malaysia
Search for more papers by this authorVeena Selvaratnam
Department of Haematology, Hospital Ampang, Selangor, Malaysia
Search for more papers by this authorAhlam Naila Kori
Department of Medical, Hospital Tengku Ampuan Afzan, Kuantan, Malaysia
Search for more papers by this authorSoo-Chin Ng
Subang Jaya Medical Center, Subang Jaya, Selangor, Malaysia
Search for more papers by this authorCorresponding Author
S. Fadilah Abdul Wahid
Pusat Terapi Sel (PTS), Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM UKM), Kuala Lumpur, Malaysia
Search for more papers by this authorNor Asiah Muhamad
Sector for Evidence-based Healthcare, National Institutes of Health, Ministry of Health Malaysia, Putrajaya, Malaysia
Search for more papers by this authorNor Azimah Ismail
Pusat Terapi Sel (PTS), Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM UKM), Kuala Lumpur, Malaysia
Search for more papers by this authorIzzah Athirah Rosli
Sector for Evidence-based Healthcare, National Institutes of Health, Ministry of Health Malaysia, Putrajaya, Malaysia
Search for more papers by this authorChiang Su Kien
Department of Medicine, Haematology Unit, Hospital Pulau Pinang, Penang, Malaysia
Search for more papers by this authorSoo Min Lim
Department of Haematology, Hospital Sultanah Aminah, Johor Bahru, Johor, Malaysia
Search for more papers by this authorLee Ping Chew
Haematology Unit, Medical Department, Sarawak General Hospital, Kuching, Sarawak, Malaysia
Search for more papers by this authorKirubamoorthy Kamini
Hospital Raja Permaisuri Bainun, Ipoh, Perak, Malaysia
Search for more papers by this authorVeena Selvaratnam
Department of Haematology, Hospital Ampang, Selangor, Malaysia
Search for more papers by this authorAhlam Naila Kori
Department of Medical, Hospital Tengku Ampuan Afzan, Kuantan, Malaysia
Search for more papers by this authorSoo-Chin Ng
Subang Jaya Medical Center, Subang Jaya, Selangor, Malaysia
Search for more papers by this authorFunding: The study is supported by Roche (Malaysia) Sdn Bhd.
ABSTRACT
Background
Polatuzumab vedotin + bendamustine + rituximab (Pola-BR) was recently approved in Malaysia for treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). A multicenter retrospective study was conducted to assess the effectiveness of this regimen among patients in a compassionate use program.
Objective
To determine treatment response and survival rates for R/R DLBCL patients treated with Pola-BR in Malaysia.
Methodology
Safety and efficacy data of 23 adults with R/R DLBCL treated with Pola-BR at nine centers in Malaysia (September 2019–February 2021) were used. Of the 23 patients, 13 received six cycles of Pola-BR. The median follow-up was 10 months (1–37 months). The primary endpoint was complete response (CR) rate; secondary endpoints were overall survival (OS), progression-free survival (PFS), and adverse events (AEs).
Results
The overall response rate was 56.5%, with 34.8% achieving CR. The 1-, 2-, and 3-year OS rates were 51.6%, 51.6%, and 44.2%, respectively, with a median OS of 27 months. The 1- and 2-year PFS rates were 48.2% and 41.3%, respectively, with a median PFS of 10 months; 60% of the nonresponders had progressive disease. Cox proportional hazard regression analysis showed that bulky disease was a significant hazard for disease progression. A total of 42 AEs were recorded, of which 66.7% were grade ≥ 3 AEs; 90.5% of the AEs were hematological and resolved with treatment; only one patient succumbed to neutropenic sepsis.
Conclusions
Pola-BR has a favorable safety profile for R/R DLBCL treatment in Malaysia, although larger sample sizes and longer follow-ups are needed to confirm these results.
Conflicts of Interest
The authors declare no conflicts of interest.
Open Research
Data Availability Statement
Data are available with the corresponding author.
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