دورية أكاديمية
Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM)
| العنوان: | Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM) |
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| المؤلفون: | Orlando L., Lorusso V., Giotta F., Di Maio M., Schiavone P., Fedele P., Quaranta A., Caliolo C., Ciccarese M., Cinefra M., Romito S., Pisconti S., Prete S. D., Aieta M., Rizzi D., Maiello E., Colucci G., Cinieri S. |
| المساهمون: | Orlando L., Lorusso V., Giotta F., Di Maio M., Schiavone P., Fedele P., Quaranta A., Caliolo C., Ciccarese M., Cinefra M., Romito S., Pisconti S., Prete S.D., Aieta M., Rizzi D., Maiello E., Colucci G., Cinieri S. |
| سنة النشر: | 2020 |
| المجموعة: | Università degli studi di Torino: AperTo (Archivio Istituzionale ad Accesso Aperto) |
| مصطلحات موضوعية: | Advanced breast cancer, HER-2 positive, Metronomic chemotherapy |
| الوصف: | Background. The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC. Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied. Results. Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1–98). ORR was 56.7% (95% CI, 44.1–68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3–4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt. Conclusions. Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/32540553; info:eu-repo/semantics/altIdentifier/wos/WOS:000573862600003; volume:53; firstpage:18; lastpage:22; numberofpages:5; journal:THE BREAST; http://hdl.handle.net/2318/1770068Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85086606712 |
| DOI: | 10.1016/j.breast.2020.06.002 |
| الإتاحة: | https://doi.org/10.1016/j.breast.2020.06.002Test http://hdl.handle.net/2318/1770068Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.7F02BF8E |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.breast.2020.06.002 |
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