Umberto Basso1, Anna Roma2, Antonella Brunello2, Cristina Falci3, Pasquale Fiduccia2, Alberto Banzato4, Antonio Bononi5, Milena Gusella5, Lampros Vamvakas6, Vittorina Zagonel2, Silvio Monfardini7. 1. Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy. Electronic address: umberto.basso@ioveneto.it. 2. Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy. 3. Division of Medical Oncology 2, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy. 4. Division of Cardiology, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy. 5. Medical Oncology, Azienda ULSS 18, Rovigo, Italy. 6. University General Hospital, Heraklion, Greece. 7. Division of Medical Oncology 1, Istituto Oncologico Veneto-IOV I.R.C.C.S., Padova, Italy; Geriatric Oncology Program, Fondazione Don Gnocchi, Milan, Italy.
Abstract
BACKGROUND: We conducted a multicenter prospective trial to assess tolerability and activity of pegylated liposomal doxorubicin (PLD) in women ≥ 70 years with locally-advanced or metastatic breast cancer. PATIENTS AND METHODS: All patients underwent Multidimensional Geriatric Assessment (MGA). Frail patients were excluded. Normal cardiac function was required for inclusion. A bi-weekly schedule of PLD at 20mg/mq was adopted. RESULTS: Thirty-two patients were enrolled with a median age of 78 years, 78.1% with visceral involvement, and 37.6% previously treated with chemotherapy for advanced disease. A mean of 7.8 cycles were delivered (range 1 to 20), with a median cumulative dose intensity of 8.9 mg/m(2)/week. Grade 3-4 toxicities were anemia (6.3%), palmar-plantar erythrodysesthesia (6.3%), mucositis (6.3%), infection (3.1%), and pulmonary embolism (3.1%). No cardiac events were registered. Causes of treatment interruption were maximal response (15.6%), progression (40.6%), refusal/loss to follow-up (28.1%), toxicities (9.4%), or other (6.3%). Response was obtained in 33.3% of 27 evaluable patients; median time to progression (TTP) was 10.3 months. MGA status (vulnerable vs. fit) did not have an impact on response, progression, and toxicity. CONCLUSIONS: Bi-weekly PLD is well tolerated in both fit and vulnerable patients, with an apparently fairly good response rate and TTP (possibly biased by subsequent endocrine therapy and loss to follow-up). Close observation of patients is recommended in order to avoid early refusal/loss to follow-up.
BACKGROUND: We conducted a multicenter prospective trial to assess tolerability and activity of pegylated liposomal doxorubicin (PLD) in women ≥ 70 years with locally-advanced or metastatic breast cancer. PATIENTS AND METHODS: All patients underwent Multidimensional Geriatric Assessment (MGA). Frail patients were excluded. Normal cardiac function was required for inclusion. A bi-weekly schedule of PLD at 20mg/mq was adopted. RESULTS: Thirty-two patients were enrolled with a median age of 78 years, 78.1% with visceral involvement, and 37.6% previously treated with chemotherapy for advanced disease. A mean of 7.8 cycles were delivered (range 1 to 20), with a median cumulative dose intensity of 8.9 mg/m(2)/week. Grade 3-4 toxicities were anemia (6.3%), palmar-plantar erythrodysesthesia (6.3%), mucositis (6.3%), infection (3.1%), and pulmonary embolism (3.1%). No cardiac events were registered. Causes of treatment interruption were maximal response (15.6%), progression (40.6%), refusal/loss to follow-up (28.1%), toxicities (9.4%), or other (6.3%). Response was obtained in 33.3% of 27 evaluable patients; median time to progression (TTP) was 10.3 months. MGA status (vulnerable vs. fit) did not have an impact on response, progression, and toxicity. CONCLUSIONS: Bi-weekly PLD is well tolerated in both fit and vulnerable patients, with an apparently fairly good response rate and TTP (possibly biased by subsequent endocrine therapy and loss to follow-up). Close observation of patients is recommended in order to avoid early refusal/loss to follow-up.