A RANDOMIZED STUDY OF TAMOXIFEN ALONE VERSUS TAMOXIFEN PLUS MELATONIN IN ESTROGEN RECEPTOR-NEGATIVE HEAVILY PRETREATED METASTATIC BREAST-CANCER PATIENTS

Author(s):  
P LISSONI ◽  
A ARDIZZOIA ◽  
S BARNI ◽  
F PAOLOROSSI ◽  
G TANCINI ◽  
...  
1999 ◽  
Vol 17 (4) ◽  
pp. 1127-1127 ◽  
Author(s):  
E. Salminen ◽  
M. Bergman ◽  
S. Huhtala ◽  
E. Ekholm

PURPOSE: Patients with metastatic breast cancer, especially those with progression after several prior chemotherapy treatments, need efficient chemotherapy. This study investigates the efficacy and toxicity of docetaxel in metastatic breast cancer patients with previous chemotherapy for metastatic disease. PATIENTS AND METHODS: Thirty-one women (median age, 52 years; range, 40 to 65 years) treated for metastatic breast cancer with docetaxel were included. Eleven patients had one metastatic site, 10 patients had two, and 10 patients had three or more. The planned dose of docetaxel per course was the standard treatment of 100 mg/m2 (or 75 mg/m2 if liver enzyme levels were abnormal) every 3 weeks, given for six or eight cycles. RESULTS: The overall response rate was 48% (three complete responses [CR] and 11 partial responses [PR] ), and the median duration of response was 7 months (range, 2 to 16 months). Twenty patients (65%) experienced fatigue, and 27 patients (87%) had alopecia. Fifteen cases (48%) of grade 4 leukopenia were observed. Edema with a weight gain of 2 to 15 kg was seen in 12 patients (39%), and mucositis occurred in 20 patients (65%). Twenty-three patients (74%) interrupted treatment before reaching the planned number of courses, nine patients owing to progression of cancer and 14 owing to toxicity. Dose reduction was required in 18 (61%) of the patients. Only two patients were able to receive the planned eight courses without dose reduction. CONCLUSION: Docetaxel is highly active in metastatic breast cancer, even as a third-line treatment, and can be considered as an efficient standard option in second-line treatment. The standard recommended dose level of 100 mg/m2 is not feasible in heavily pretreated patients; therefore, for such patients, an initial dose level not exceeding 75 mg/m2 is recommended.


2010 ◽  
Vol 28 (S1) ◽  
pp. 115-120 ◽  
Author(s):  
Ellen B. Kossoff ◽  
Nuttapong Ngamphaiboon ◽  
Thomas J. Laudico ◽  
Tracey L. O’Connor

Oncology ◽  
2005 ◽  
Vol 69 (5) ◽  
pp. 408-413 ◽  
Author(s):  
M. Donadio ◽  
M. Ardine ◽  
A. Berruti ◽  
A. Beano ◽  
A. Bottini ◽  
...  

2015 ◽  
Vol 11 (3) ◽  
pp. 431-438 ◽  
Author(s):  
Alessandra Fabi ◽  
Luca Moscetti ◽  
Mariangela Ciccarese ◽  
Miriam Caramanti ◽  
Nello Salesi ◽  
...  

2020 ◽  
Author(s):  
katsuhiko nakatsukasa ◽  
Naoki Niikura ◽  
Kosuke Kashiwabara ◽  
Takeshi Amemiya ◽  
Kenichi Watanabe ◽  
...  

Abstract Background: The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients that received POC to those that had not and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE. Methods: Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated by an oncologist over 8 weeks between groups. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months. Results: There were no significant differences in PFS between the POC and Control Groups ( P = 0.801). A BMI < 25 mg/m 2 and non-visceral metastasis were associated with longer PFS ( P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS ( P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial. Conclusions: POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI < 25 mg/m 2 , and who did not receive BMA while receiving EVE and EXE may have better prognoses. Trial registration: The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov (NCT02376985).


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1071-1071
Author(s):  
Anantbhushan Ranade ◽  
Kanaka Govind Babu ◽  
Purvish M. Parikh ◽  
Jk Singh ◽  
Manisha Singh ◽  
...  

1071 Background: Metronomic chemotherapy regimens have shown efficacy in patients with metastatic breast cancer by antiangiogenic mechanisms. When used metronomically the toxicity profile of capecitabine is low. Triple negative breast cancer is a common problem in India and developing countries. Approximately 30% of triple negative breast cancer express EGFR and its mutation. Methods: Since October 2003 to December 2011 we objectively tested response rates, clinical benefit, and safety of gefitinib and capecitabine administered with a metronomic schedule of 500 mg thrice daily in heavily pretreated metastatic breast cancer patients with gefitinib 250 mg once daily. 300 patients were screened for EGFR expression. Among 85 enrolled patients with EGFR positivity, 76 were evaluable. ECOG performance status (PS) was 0-2, median age 52 years (range 36-65), bone plus visceral metastasis in 40% of patients. Rest had only visceral metastasis. All the patients were pretreated with anthracyclines and taxanes. The combination was administered for a median duration of 32 weeks (range 12-166). Results: We observed 18 partial responses (PR: 24%), 42 (55%) stable disease (SD). Median time to progression was 53 weeks, (95% CI, range 12-166 weeks). Safety of metronomic capecitabine with gefitinib was excellent. Neither grade 2-4 haematological or clinical side effects were recorded. Only 12 patients experienced grade I (WHO) hand-foot syndrome. Conclusions: Treatment with metronomic capecitabine and gefitinib was effective and minimally toxic in heavily pretreated breast cancer patients.


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