A phase 2 study of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines with/without taxanes.

BACKGROUND AND OBJECTIVES: Many patients with relapsed metastatic breast cancer are pre-treated with taxanes and anthracyclines, which are usually given in the neoadjuvant/adjuvant setting or as first-line treatment for metastatic disease. The primary objective of this study was to determine the overall response rate for combination treatment with gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who had relapsed after receiving one adjuvant/neoadjuvant or first-line metastatic chemotherapy regimen containing an anthracycline with/without a taxane. Secondary endpoints included duration of response, time to progression, one-year survival probability, and toxicity. DESIGN AND SETTING: A single-arm, open-label, phase 2 study conducted at 17 investigative sites in Egypt. PATIENTS AND METHODS: treatment consisted of gemcitabine (1250 mg/m2) on Days 1 and 8 and cisplatin (70 mg/m2) on Day 1 of each 21-day cycle. Treatment continued until disease progression or a maximum of 6 cycles. RESULTS: Of 144 patients all were evaluable for safety and 132 patients were evaluable for efficacy. The overall response rate was 33.3% and 45.5% of the patients with stable disease as their best response. The median time-to-progression was 5.1 months and the one-year survival probability was 73%. The most common grade 3/4 adverse events were nausea/vomiting (20.1%), neutropenia (19.4%), anemia (13.9%), asthenia (11.1%), diarrhea (9.7%), stomatitis (7.6%), leucopenia (7.6%), and thrombocytopenia (6.2%). twelve (8.3%) patients had serious adverse events. CONCLUSIONS: The results of this study indicate that gemcitabine and cisplatin were active and generally well tolerated in pretreated patients with locally advanced or metastatic breast cancer.

Characteristics and control of the normal menstrual cycle.

The most important activity during the follicular phase of the cycle is the secretion of gonadotropins, which control folliculogenesis and influence uterine proliferation. The dominant events of the periovulatory phase are the LH surge and ovulation. The significant change during the luteal phase is the production of a nutritive mucus by the endometrial glands in preparation for an embryonic blastocyst. The cardinal passage of the menstrual phase is the menstrual flow itself. These different events (and the metabolic processes that regulate them) have wide-ranging effects on the integrity of the body. As Havelock Ellis, the eminent English psychologist, stated at the turn of this century, "the omnipresent process of sex, as it is woven into the whole texture of our body, is the pattern of all the process of our life" (source unknown). The sweeping influences of the menstrual cycle illustrate the extent to which the process of reproduction is indeed woven into the whole of the human body.