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DOI 10.1093/annonc/mdr001

Медицинская библиотека · Annals of oncology : official journal of the European Society for Medical Oncology · 2011

Ovarian cancer in elderly patients: carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in late relapse: a Gynecologic Cancer Intergroup (GCIG) CALYPSO sub-study.

Kurtz J E, Kaminsky M C, Floquet A, Veillard A S, Kimmig R, Dorum A, Elit L, Buck M, Petru E, Reed N, Scambia G, Varsellona N, Brown C, Pujade-Lauraine E, Gynecologic Cancer Intergroup

Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

BACKGROUND

CALYPSO (CAeLYx in Platinum Sensitive Ovarian) patients compared carboplatin-pegylated liposomal doxorubicin (C-PLD) with carboplatin-paclitaxel (C-P) in patients with late-relapsing recurrent ovarian cancer (ROC). We analyzed outcomes in patients ≥70 years.

PATIENTS AND

METHODS

Nine hundred and seventy-six patients with taxane-pretreated ROC relapsing >6 months after first- or second-line platinum-based therapy were randomly assigned to 4-weekly C area under the curve (AUC) 5 plus PLD 30 mg/m(2) or 3-weekly C AUC 5 plus P 175 mg/m(2) for six or more cycles.

RESULTS

One hundred and fifty-seven (16%) patients ≥70 years (median: 74 years, C-PLD; 73 years, C-P; range 70-82 years) were included (n = 71, C-PLD; n = 86, C-P). In comparing elderly and younger, elderly patients experienced fewer grade ≥2 allergic reactions (P = 0.005) but more grade ≥2 sensory neuropathy (P = 0.007). Myelosuppression did not differ with age. Elderly patients completed planned treatment as frequently as younger (79%, C-PLD; 82%, C-P). In comparing arms within elderly patients, C-P was associated with more grade ≥2 alopecia, sensory neuropathy, arthralgia/myalgia (P < 0.001 for all), severe leukopenia plus febrile neutropenia; C-PLD was associated with more grade ≥2 hand-foot syndrome (P = 0.005). Median progression-free survival was 11.6 months (C-PLD) and 10.3 months (C-P; P = 0.44).

CONCLUSIONS

Patients ≥70 years experienced more neuropathy, with a higher incidence in the C-P arm. Similar to all study patients, C-PLD provided a better therapeutic index with less toxicity than C-P in elderly women with platinum-sensitive ROC.

Для цитирования: Kurtz J E, Kaminsky M C, Floquet A, Veillard A S, Kimmig R, Dorum A, Elit L, Buck M, Petru E, Reed N, Scambia G, Varsellona N, Brown C, Pujade-Lauraine E, Gynecologic Cancer Intergroup. Ovarian cancer in elderly patients: carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in late relapse: a Gynecologic Cancer Intergroup (GCIG) CALYPSO sub-study.. Annals of oncology : official journal of the European Society for Medical Oncology. 2011. DOI: 10.1093/annonc/mdr001.

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