scholarly journals Outcomes analysis of an alternative formulation of PEGylated liposomal doxorubicin in recurrent epithelial ovarian carcinoma during the drug shortage era

2014 ◽  
pp. 1409
Author(s):  
Thomas Krivak ◽  
Ashlee Smith ◽  
Kristin Zorn ◽  
Paniti Sukumvanich ◽  
Alexander B. Olawaiye ◽  
...  
Author(s):  
Hsin-Ying Huang ◽  
Chun-Ju Chiang ◽  
Yun-Yuan Chen ◽  
San-Lin You ◽  
Heng-Cheng Hsu ◽  
...  

We aimed to evaluate factors influencing the outcomes of patients with platinum-sensitive recurrent epithelial ovarian carcinoma (EOC). Patients with advanced-stage EOC, who received debulking surgery and adjuvant chemotherapy for recurrence, were obtained from the National Health Insurance Research database of Taiwan between 2000 and 2013. A total of 1038 patients with recurrent advanced-stage EOC were recruited. The platinum + paclitaxel (PT) group had the best five-year overall survival (OS) compared with the other three groups (p < 0.001). The hazard ratios (HRs) of five-year OS for the platinum + liposomal doxorubicin (PD), topotecan (TOP), and pegylated liposomal doxorubicin (PLD) groups were 1.21 (p = 0.07), 1.35 (p = 0.016), and 1.80 (p < 0.001), respectively, compared with the PT group. The PT group also had lower hazard ratios of five-year OS for patients with platinum therapy-free interval (TFIp) between 6 and 12 months compared with the other three groups (p < 0.0001). However, the HRs of five-year OS did not differ between the PT and PD groups in patients with TFIp >12 months. Patients with TFIp >12 months had lower HRs of five-year OS compared with those with TFIp of 6–12 months, regardless of whether they were treated with platinum-based (p = 0.001) or non-platinum-based (p = 0.003) regimens. Chemotherapeutic regimens and TFIp influenced the outcomes of patients with recurrent EOC. For patients with TFIp of 6–12 months, the PT regimen is the first choice based on their best overall survival result. For patients with TFIp >12 months, either platinum-based or non-platinum regimens could be used because of their similar excellent overall survival.


2001 ◽  
Vol 19 (14) ◽  
pp. 3312-3322 ◽  
Author(s):  
Alan N. Gordon ◽  
John T. Fleagle ◽  
David Guthrie ◽  
David E. Parkin ◽  
Martin E. Gore ◽  
...  

PURPOSE: To compare the efficacy and safety of pegylated liposomal doxorubicin (PLD) and topotecan in patients with epithelial ovarian carcinoma that recurred after or didn’t respond to first-line, platinum-based chemotherapy. PATIENTS AND METHODS: Patients with measurable and assessable disease were randomized to receive either PLD 50 mg/m2 as a 1-hour infusion every 4 weeks or topotecan 1.5 mg/m2/d for 5 consecutive days every 3 weeks. Patients were stratified prospectively for platinum sensitivity and for the presence or absence of bulky disease. RESULTS: A total of 474 patients were treated (239 PLD and 235 topotecan). They comprised the intent-to-treat population. The overall progression-free survival rates were similar between the two arms (P = .095). The overall response rates for PLD and topotecan were 19.7% and 17.0%, respectively (P = .390). Median overall survival times were 60 weeks for PLD and 56.7 weeks for topotecan. Data analyzed in platinum-sensitive patients demonstrated a statistically significant benefit from PLD for progression-free survival (P = .037), with medians of 28.9 for PLD versus 23.3 weeks for topotecan. For overall survival, PLD was significantly superior to topotecan (P = .008), with a median of 108 weeks versus 71.1 weeks. The platinum-refractory subgroup demonstrated a nonstatistically significant survival trend in favor of topotecan (P = .455). Severe hematologic toxicity was more common with topotecan and was more likely to be associated with dosage modification, or growth factor or blood product utilization. CONCLUSION: The comparable efficacy, favorable safety profile, and convenient dosing support the role of PLD as a valuable treatment option in this patient population.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5064-5064 ◽  
Author(s):  
Franziska Kluschke ◽  
Anja Martschick ◽  
Maxim E. Darvin ◽  
Leonhard Zastrow ◽  
Radoslav Chekerov ◽  
...  

5064 Background: Pegylated liposomal doxorubicin has proved to be highly efficient in the treatment of various tumors. Depending on the application protocol, up to 80% of patients develop palmar-plantar erythrodysesthesia (PPE). So far, a prevention strategy is still unknown. Recently, it was shown that parts of the chemotherapeutics were excreted with the sweat onto the skin surface, spreading there homogeneously and penetrating into the stratum corneum. The formation of free radicals in the tissue results in PPE. The aim of the study was to investigate if a topically applied ointment containing antioxidants with high radical protection factor (RPF) can be a PPE prevention strategy. Methods: 20 patients with ovarian carcinoma, who had been treated with pegylated liposomal doxorubicin (40 mg/m2), were investigated. They applied the ointment at least twice daily, 2 days before and during 3 cycles of chemotherapy. Their skin condition was examined by a trained dermatologist. Results: From 20 patients enrolled in the study, only 12 (60%) met the conditions by applying the cream at least twice daily in the palmar and plantar regions. These patients did not develop PPE. One patient died in the 2nd cycle of therapy. 7 patients (35%) did not follow the ointment application protocol for various reasons; 6 of them developed PPE and resumed ointment application thereafter. As a result, PPE disappeared or was strongly reduced in these patients so that chemotherapy could be continued. Due to the small group of patients, the fact that PPE was not induced in patients who had applied the ointment regularly can be generalized only restrictedly. Far more interesting are the findings in those patients, who had stopped ointment application during chemotherapy and developed PPE, which disappeared after they resumed applying the ointment. The regression or distinct reduction of PPE after re-application of the ointment clearly proves the efficacy of this strategy. Conclusions: The topical application of an ointment containing antioxidants with high radical protection factor (RPF) could be an efficient strategy against the development of PPE during chemotherapy.


Cancer ◽  
2001 ◽  
Vol 91 (1) ◽  
pp. 90-100 ◽  
Author(s):  
Tamar Safra ◽  
Susan Groshen ◽  
Susan Jeffers ◽  
Denice D. Tsao-Wei ◽  
Linyun Zhou ◽  
...  

2005 ◽  
Vol 16 (2) ◽  
pp. 300-306 ◽  
Author(s):  
D. Katsaros ◽  
M.V. Oletti ◽  
I.A. Rigault de la Longrais ◽  
A. Ferrero ◽  
A. Celano ◽  
...  

2020 ◽  
Vol 40 (5) ◽  
pp. 2497-2507
Author(s):  
OSAMU MAEDA ◽  
HIROAKI KAJIYAMA ◽  
KIYOSUMI SHIBATA ◽  
SHIGEO NAKAMURA ◽  
FUMITAKA KIKKAWA

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