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
Department of Internal Medicine, Medical Center Alkmaar, Alkmaar.
Comprehensive Cancer Center the Netherlands, Amsterdam.
Ann Oncol. 2014 Mar;25(3):599-605. doi: 10.1093/annonc/mdt588. Epub 2014 Feb 6.
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 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).
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.
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.
EudraCT 2006-002046-10; ISRCTN 11114726; CKTO 2006-09; BOOG 2006-02.
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。
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。
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。
EudraCT 2006 - 002046 - 10；ISRCTN 11114726；CKTO 2006 - 09；BOOG 2006 - 02。
