Randomized Phase II Trial on Mitomycin-C/Cisplatin ± KLT in Heavily Pretreated Advanced Breast Cancer

Abstract

A randomized phase II study using mitomycin (MMC)/cisplatin (DDP) regimen with or without Kanglaite (KLT, a traditional Chinese medicine) as salvage treatment was conducted to exploit KLT's potential effects on patients with advanced breast cancer (ABC). Triweekly regimen consisted of mitomycin (8 mg/m(2)) administered intravenously on day 1, and cisplatin (25 mg/m(2)) intravenously on days 1 to 3. KLT (100 ml) was given intravenously per day on days 1 to 14 every 3 weeks. Between April 2006 and July 2007, 60 patients with a median age of 48 years were randomized into MMC/DDP with or without KLT treatment. In all, the objective response rate (ORR) was 17.5%. There were no significant differences between experimental and control treatments in terms of ORR (14.3% vs. 20.7%, p = 0.730), clinical benefit rates (24.1% vs. 28.6%, p = 0.468), median time to progression (TTP; 3.63 vs. 4.0, p = 0.872), and overall survival (OS; 7.17 vs. not reached, p = 0.120). The median TTP for patients with complete or partial responses was 6.0 months, but only 2.1 months for patients with stable or progressive disease (SD or PD; p = 0.028). While the median OS for patients who obtained clinical benefit from chemotherapy was not reached, that of patients with SD of no more than 6 months or PD was only 7.17 months (p = 0.004). There is no additional benefit when KLT is added to the MMC/DDP doublet in the management of ABC. Patients who obtained clinical benefit from chemotherapy had a longer TTP and OS.

Herbal Interactions with Anticancer Drugs: Mechanistic and Clinical Considerations

“…The overall objective response rate was 17.5% [95]. There were no significant differences between triple therapy and control treatments in terms of objective response rate, clinical benefit rates, median time to progression, and overall survival [95]. These data indicate that Kanglaite does not cause additional benefit when it is added to the mitomycin-C/cisplatin regimen in the management of advanced breast cancer patients.…”

“…Kanglaite (100 ml) was given intravenously per day on days 1 to 14 every 3 weeks. The overall objective response rate was 17.5% [95]. There were no significant differences between triple therapy and control treatments in terms of objective response rate, clinical benefit rates, median time to progression, and overall survival [95].…”

“…A recent randomized Phase II study in Shanghai of China using mitomycin-C/cisplatin regimen with or without Kanglaite as salvage treatment was conducted on patients with advanced breast cancer (n = 60) [95]. The triweekly regimen consisted of mitomycin-C (8 mg/m 2 ) administered intravenously on day 1, and cisplatin (25 mg/m 2 ) intravenously on days 1 to 3.…”

Traditional Chinese medicine in the prevention and treatment of cancer and cancer metastasis

“…It has been reported that KLT is able to inhibit cellular mitosis during the G 2 /M phase of the cell cycle and promote apoptosis via the Fas/FasL pathway (44). A phase Ⅰ study indicated that there was no marked toxicity when the KLT injection was administered at the maximum dose of 50,000 mg/day in the first cycle (45). KLT has been widely used in combination with chemotherapy for the treatment of non-small cell lung cancer.…”

Antitumor effect of Kanglaite® injection in human pancreatic cancer xenografts

“…Coix seed is a Chinese herbal medicine that is used in the treatment of hypertension, arthritis, cancer metastasis, asthma, and immunological disorders [3]. The main ingredient of Kanglaite® injection (KLT) is Coix seed oil [4], and it has been widely used for cancer treatment in China [5]. …”