一项比较聚乙二醇化脂质体阿霉素与卡培他滨作为老年转移性乳腺癌患者一线化疗方案的随机III期研究：荷兰乳腺癌研究组BOOG的OMEGA研究结果
A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: results of the OMEGA study of the Dutch Breast Cancer Research Group BOOG.
作者信息
Smorenburg C H, de Groot S M, van Leeuwen-Stok A E, Hamaker M E, Wymenga A N, de Graaf H, de Jongh F E, Braun J J, Los M, Maartense E, van Tinteren H, Nortier J W R, Seynaeve C
机构信息
Department of Internal Medicine, Medical Center Alkmaar, Alkmaar.
Comprehensive Cancer Center the Netherlands, Amsterdam.
出版信息
Ann Oncol. 2014 Mar;25(3):599-605. doi: 10.1093/annonc/mdt588. Epub 2014 Feb 6.
BACKGROUND
Prospective data on chemotherapy for elderly patients with metastatic breast cancer (MBC) remain scarce. We compared the efficacy and safety of first-line chemotherapy with pegylated liposomal doxorubicin (PLD) versus capecitabine in MBC patients aged ≥65 years in a multicentre, phase III trial.
PATIENTS AND METHODS
Patients were randomized to six cycles of PLD (45 mg/m(2) every 4 weeks) or eight cycles of capecitabine (1000 mg/m(2) twice daily, day 1-14 every 3 weeks).
RESULTS
The study enrolled 78 of the planned 154 patients and was closed prematurely due to slow accrual and supply problems of PLD. Many included patients were aged ≥75 years (54%) and vulnerable (≥1 geriatric condition: 71%). The median dose intensity was 85% for PLD and 84% for capecitabine, respectively. In both arms, the majority of patients completed at least 12 weeks of treatment (PLD 73%; capecitabine 74%). After a median follow-up of 39 months, 77 patients had progressed and 62 patients had died of MBC. Median progression-free survival was 5.6 versus 7.7 months (P = 0.11) for PLD and capecitabine, respectively. Median overall survival was 13.8 months for PLD and 16.8 months for capecitabine (P = 0.59). Both treatments were feasible, grade 3 toxicities consisting of fatigue (both arms: 13%), hand-foot syndrome (PLD: 10%; capecitabine: 16%), stomatitis (PLD: 10%; capecitabine: 3%), exanthema (PLD: 5%) and diarrhoea (PLD: 3%; capecitabine: 5%). Only 1 of 10 patients aged ≥80 years completed chemotherapy, while 3 and 6 patients discontinued treatment due to toxicity or progressive disease, respectively.
CONCLUSION
Both PLD and capecitabine demonstrated comparable efficacy and acceptable tolerance as first-line single-agent chemotherapy in elderly patients with MBC, even in vulnerable patients or patients aged ≥75 years. However, patients aged ≥80 years were unlikely to complete chemotherapy successfully.
CLINICAL TRIAL NUMBERS
EudraCT 2006-002046-10; ISRCTN 11114726; CKTO 2006-09; BOOG 2006-02.
背景
有关老年转移性乳腺癌（MBC）患者化疗的前瞻性数据仍然很少。我们在一项多中心III期试验中比较了聚乙二醇化脂质体阿霉素（PLD）与卡培他滨作为≥65岁MBC患者一线化疗的疗效和安全性。
患者与方法
患者被随机分为接受6个周期的PLD（每4周45mg/m²）或8个周期的卡培他滨（1000mg/m²，每日2次，第1 - 14天，每3周重复）治疗。
结果
该研究纳入了计划的154例患者中的78例，由于入组缓慢和PLD供应问题而提前结束。许多纳入的患者年龄≥75岁（54%）且身体状况较差（≥1种老年疾病：71%）。PLD和卡培他滨的中位剂量强度分别为85%和84%。在两组中，大多数患者完成了至少12周的治疗（PLD组73%；卡培他滨组74%）。中位随访39个月后，77例患者病情进展，62例患者死于MBC。PLD组和卡培他滨组的中位无进展生存期分别为5.6个月和7.7个月（P = 0.11）。PLD组的中位总生存期为13.8个月，卡培他滨组为16.8个月（P = 0.59）。两种治疗方法均可行，3级毒性包括疲劳（两组均为13%）、手足综合征（PLD组：10%；卡培他滨组：16%）、口腔炎（PLD组：10%；卡培他滨组：3%）、皮疹（PLD组：5%）和腹泻（PLD组：3%；卡培他滨组：5%）。≥80岁的10例患者中只有1例完成了化疗，分别有3例和6例患者因毒性或疾病进展而停止治疗。
结论
PLD和卡培他滨作为老年MBC患者的一线单药化疗，疗效相当且耐受性可接受，即使是身体状况较差的患者或≥75岁的患者。然而，≥80岁的患者不太可能成功完成化疗。
临床试验编号
EudraCT 2006 - 002046 - 10；ISRCTN 11114726；CKTO 2006 - 09；BOOG 2006 - 02。
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