A comparison of overall survival with 40 and 50mg/m2pegylated liposomal doxorubicin treatment in patients with recurrent epithelial ovarian cancer: Propensity score-matched analysis of real-world data.
BACKGROUND
In clinical practice, 40mg/m2of pegylated liposomal doxorubicin (PLD40) has been used as an initial dosage for treating recurrent epithelial ovarian cancer (OC) instead of the recommended dose of 50mg/m2(PLD50). However, no robust evidence is available to support the use of PLD40. This post-hoc study aimed to compare the efficacy and safety of initial PLD dosages in propensity score (P-score)-matched dataset.


METHODS
The data source was a PLD postmarketing surveillance dataset (n=2189) conducted in Japan. Eligibility criteria for the present study were as follows: recurrent OC, history of chemotherapy, and treatment with PLD monotherapy at a dosage between 35.5 and 54.4mg/m2. Overall survival (OS) was compared between PLD50- and PLD40-treated groups using the log-rank test. Incidences of palmar-plantar erythrodysesthesia (PPE) and stomatitis were also compared between the groups.


RESULTS
Overall, 503 matched pairs were generated using P-score analysis. The median survival time with PLD50 and PLD40 was 383 and 350days, respectively, with a hazard ratio of 1.10 (95% confidence interval, 0.98-1.26; p=0.211), although the difference was not statistically significant in the P-score-matched dataset. However, the incidence and severity of PPE and stomatitis were significantly lower with PLD40.


CONCLUSIONS
Our study showed that the efficacy of PLD did not differ based on initial dosages, but the risk of adverse events was reduced with PLD40. Considering the balance between patient benefits and risks, our results support the use of PLD40 in clinical practice.
Medical Affairs Division, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo 101-0065, Japan. Electronic address: mnakayam@its.jnj.com.
Masahiko
M
Nakayama
Medical Affairs Division, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo 101-0065, Japan. Electronic address: hkobaya1@its.jnj.com.
Hisanori
H
Kobayashi
Medical Affairs Division, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo 101-0065, Japan. Electronic address: ttakahar@its.jnj.com.
Tomihiro
T
Takahara
Medical Affairs Division, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo 101-0065, Japan. Electronic address: ynishim1@its.jnj.com.
Yukiko
Y
Nishimura
Medical Affairs Division, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo 101-0065, Japan. Electronic address: kfukush@its.jnj.com.
Koji
K
Fukushima
Medical Affairs Division, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo 101-0065, Japan. Electronic address: kyoshiz1@its.jnj.com.
Kazutake
K
Yoshizawa
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use; D057216:Propensity Score
D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin
Hand-foot syndrome; Liposomal doxorubicin; Mortality; Ovarian neoplasms; Propensity score; Stomatitis