Abstract
In this study, the maximum tolerated dose (MTD) of lobaplatin (LBP) when it was combined with docetaxel (TXT) for the treatment of solid tumours that had progressed following chemotherapy was determined, and toxicities to this regimen were evaluated. A modified Fibonacci method was used for the dose escalation of LBP. The patients received TXT (at a fixed dose of 60 mg/m2) on day one (d1) and LBP (at an initial tested dose of 30 mg/m2) on day two (d2) of a treatment cycle that was repeated every 21 days. Each dose group consisted of at least three cases. In the absence of dose-limiting toxicity (DLT), we proceeded to the next dose group, with a dose increment of 5 mg/m2 between groups, until DLT occurred. The dose immediately below the dose that produced DLT was regarded as the MTD. The 17 patients examined in this study completed a total of 58 cycles of chemotherapy, and a total of three dose-escalation groups (30 mg/m2 LBP, 35 mg/m2 LBP, and 40 mg/m2 LBP) were established. The main adverse event that was observed was myelosuppression. DLT occurred in four patients, including three patients in the 40 mg/m2 LBP group and one patient in the 35 mg/m2 LBP group. In total, three out of the four patients in the 40 mg/m2 LBP group exhibited DLT. We determined that the treatment administered to the 35 mg/m2 LBP group represented the MTD. Thus, our phase I trial revealed that the MTD for the tested LBP combination regimen was 35 mg/m2 LBP and 60 mg/m2 TXT. This regimen resulted in mild adverse reactions and favourable patient tolerance. Therefore, we recommend the use of these dosages in phase II clinical trials.
Highlights
Statistics indicate that the incidence of cancer in China is increasing each year [1]
To further investigate the appropriate LBP dose in the aforementioned combination regimen, we conducted a dose escalation trial for LBP in this regimen; this study reports the results of this trial
A total of 14 patients among the entire group of study subjects were evaluable for efficacy; all 17 patients were evaluable for toxicity (Table I)
Summary
Statistics indicate that the incidence of cancer in China is increasing each year [1]. The clinical diagnosis of many Chinese patients occurs when these individuals have late‐stage cancer and no longer have the opportunity to receive radical surgical treatment. Chemotherapy has become an important method of cancer treatment, most patients undergo either relapse or metastasis following first‐line chemotherapy, requiring second‐line and subsequent treatments. Cisplatin (DDP)‐based chemotherapy is significant in cancer treatment; due to its toxicity, nephro- and neuro-toxicity, DDP‐based chemotherapy has limited applications [2,3]. Researchers have pursued a new platinum compound.
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