Pegylated liposomal doxorubicin hydrochloride (PLD) for advanced sarcomas in children: Preliminary results

2004 ◽  
Vol 43 (2) ◽  
pp. 152-155 ◽  
Author(s):  
Arturo Muñoz ◽  
M. Maldonado ◽  
N. Pardo ◽  
J.M. Fernández ◽  
E. Vela ◽  
...  
Keyword(s):  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Doxorubicin Hydrochloride ◽  
Preliminary Results

A double-blind randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin hydrochloride-related palmar-plantar erythrodysesthesia

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5594-5594
Author(s):  
V. E. Von Gruenigen ◽  
H. Frasure ◽  
N. Fusco ◽  
E. Eldermire ◽  
S. Eaton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Liposomal Doxorubicin ◽  
Assessment Tool ◽  
Pegylated Liposomal Doxorubicin ◽  
Doxorubicin Hydrochloride ◽  
Double Blind ◽  
Group A ◽  
Group B

5594 Background: To compare the efficacy of pyridoxine versus placebo in the prevention of palmar-plantar erythrodysesthesia (PPE) and on quality of life (QOL) in patients treated with pegylated liposomal doxorubicin hydrochloride for ovarian, breast, or endometrial cancer. Methods: All patients received pegylated liposomal doxorubicin hydrochloride 40 mg/m2 IV q 4 weeks over 1 hour every 28 days for a maximum of 6 cycles. Patients received pyridoxine 100 mg (group A) by mouth or placebo (group B) twice daily. Nurses conducted standard PPE education for all patients. Patients with Grade 2 or 3 PPE that persisted despite dose reductions/delays were unblinded, and were given pyridoxine if taking placebo. Patients completed the Functional Assessment of Cancer Therapy (FACT) assessment tool. Analyses were conducted by group and comparisons were also made between patients who experienced grade 2/3 PPE versus grade 0/1. Chi-square or Fisher's exact test were used. Results: Thirty-four patients were enrolled with 18 randomized to group A and 16 to group B. Mean age was 64 years (SD=9.6; range 45–81 years). Five patients (group A, 3; group B, 2) were unevaluable (due to pegylated liposomal doxorubicin hydrochloride reaction during first chemotherapy cycle). Overall 15/29 (52%) patients had incidence of PPE (all grades), with 10/29 (34%) having grade 2/3 events (no grade 4 events observed). In group A, 8/15 (53%) patients had a PPE event and 7/14 (50%) in group B; p=0.857. For grade 2/3 events, there was no difference as 6/15 (40%) occurred in group A and 4/14 (29%) in group B; p=0.70. There were no differences in global or domain QOL scores between those patients with Grade 2/3 PPE versus Grade 0/1. Less than half [4/10 (40%)] of patients with Grade 2/3 PPE reported being bothered by side effects of pegylated liposomal doxorubicin hydrochloride treatment. Conclusions: As administered in this study, pyridoxine did not prevent PPE in patients treated with pegylated liposomal doxorubicin hydrochloride. Quality of life differences were not observed; however, not all patients with PPE reported being bothered by side effects of pegylated liposomal doxorubicin hydrochloride treatment. Pyridoxine is not indicated for prevention of PPE during chemotherapy. [Table: see text] [Table: see text]

Lenalidomide, bortezomib, pegylated liposomal doxorubicin hydrochloride, and dexamethasone in newly diagnosed multiple myeloma: Initial results of phase I/II MMRC trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8517-8517
Author(s):  
A. J. Jakubowiak ◽  
C. C. Hofmeister ◽  
E. L. Campagnaro ◽  
T. M. Zimmerman ◽  
R. L. Schlossman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase I ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Maximum Tolerated Dose ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Doxorubicin Hydrochloride ◽  
Highly Active ◽  
Level 2

8517 Background: Three-drug combinations with lenalidomide (Revlimid, Rev) and bortezomib (Velcade, Vel) are highly active in previously untreated multiple myeloma (MM). Among the most active are RVD (Revlimid, Velcade, Dexamethasone) and VDD (Velcade, Doxil, Dexamethasone) with ≥ PR rate of 100% and 93%, and a CR/nCR rate of 44% and 40%, respectively. Pre-clinical evaluations suggest that adding pegylated liposomal doxorubicin hydrochloride (Doxil, Dox) to RVD (RVDD) may have higher activity. This phase I/II study was designed to determine the maximum tolerated dose (MTD) of RVDD, assess safety and evaluate efficacy of this 4-drug regimen in newly diagnosed MM. Methods: Four dose levels are being evaluated: Rev 15–25 mg (days 1–14), Vel 1.3 mg/m2 (days 1, 4, 8, 11), dexamethasone (Dex) 20/10 mg (cycles 1–4/5–8; days of and after Vel), Dox 20 and 30 mg/m2 (day 4), with dose assignment for patients (pts) according to the TITE-CRM algorithm. Eight 21-day cycles are planned with 38 pts to be treated at the MTD in phase II. Pts who achieve ≥ PR can proceed to autologus stem cell transplant (ASCT) after ≥ 4 cycles, while all others receive 21-day maintenance cycles with Rev (days 1–14), Vel (day 1 and 8), and Dex (days of and after Vel) at the doses tolerated by the end of initial treatment. Results: The study has enrolled 23 pts to date. Four pts received level 1 (Rev/Dox 15/20), 11 pts level 2 (Rev/Dox 20/20, and 8 pts level 3 (Rev/Dox 25/20). Nineteen pts are evaluable for toxicity after completion of a median of 4 cycles (range 1–8). Two pts developed DLT at dose level 2, consisting of grade (G) 3 asymptomatic neutropenia and G3 elevation of transaminase. The MTD has not been reached. Overall, toxicities have been manageable with no additional G3 hematologic events. There have been 4 additional G3 non-hematologic events including one case each of pneumonia, DVT, fatigue, and hypotension. After a median of 12 (range 3–24) weeks of treatment, preliminary response rates by modified EBMT/UC in 19 evaluable pts are: 95% ≥ PR, 47% ≥ VGPR, 26% CR/nCR. Conclusions: RVDD is well tolerated in newly diagnosed MM and appears highly active with an overall response (≥ PR) of 95%. Accrual is ongoing, with updated toxicity and efficacy data to be presented at the meeting. [Table: see text]

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