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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

1358 - Role of Liposomal Doxorubicin as a first line agent with VTd regimen in newly diagnosed Multiple Myeloma

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Tumour Site

Multiple Meyloma

Presenters

Mansi Khanderia

Citation

Annals of Oncology (2018) 29 (suppl_8): viii359-viii371. 10.1093/annonc/mdy286

Authors

M. Khanderia1, G. Badarkhe2, S. Bj3, R. Naik3

Author affiliations

  • 1 Medical Oncology, HCG Bangalore Institute of Oncology Speciality Centre, 560027 - Bangalore/IN
  • 2 Hematology And Bone Marrow Transplant, HCG Hospital, 560027 - Bangalore/IN
  • 3 Medical Oncology, HCG Hospital, 560027 - Bangalore/IN
More

Resources

Abstract 1358

Background

Triple drug regimens are standard of care in newly diagnosed Multiple Myeloma (MM). Studies show 4 drug regimens to be highly active. In an economically backward country like India, newer drugs and Autologous transplant may not always be feasible because of financial constraints. We studied the effect of adding Pegylated Liposomal Doxorubicin (PLD) to standard regimen on the Response Rates (RR).

Methods

60 newly diagnosed cases of MM were included in this double armed prospective, observational, comparative study. Patients were randomly assigned into 2 arms (30 Patients in each arm). Arm A consisted of VTd regimen (Inj. Bortezomib Day (D)1, D8, D15, D22 1.3mg/ / m2, Tab. Thalidomide Daily 100mg, Inj. Dexamethasone D1, D8, D15, D22 40 mg / once in 28 days). Arm B consisted of VTdD regimen (PLD D1 i.v 30mg / m2 + VTd). Hematological and biochemical parameters were noted at baseline and after completion of 4 cycles. Response assessment was done as per the criteria defined by International Myeloma Working Group (IMWG). The outcomes between the two treatment arms in terms of RR were compared.

Results

Table: 1023P

RRVTdVTdD
Overall Response Rates86.6%93.3%
>very good partial response73.3%86.6%
Stringent Complete Response33.3%53.3%

The differences in sCR rates were clinically very significant. However, on application of Pearson chi-square test significance p of 0.118 was seen, which maybe attributed to the lower power of the study. Poorest responses noted were highest in the 71-80 age group. Both the regimens were equally effective in ISS B patients. Neutropenia, thrombocytopenia, infections, mucositis, edema, dizzininess/somnolence and DVT were not significantly different between the two arms (P > 0.05). Palmar–plantar erythrodysesthesia (PPE) was the only new complication seen in (10%) VTdD group. Grade 3–4 toxicities were similar in both arms.

Conclusions

The role of liposomal doxorubicin in first line setting as a 4th agent along with triple drug regimen in treatment of MM looks promising, especially in countries with financial constraints for the newer drugs. Larger studies are needed to validate this.

Clinical trial identification

Legal entity responsible for the study

Scientific and Ethics Committee at HCG Hospital, Bangalore, India.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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