Lipoplatin in patients with renal insufficiency
In 2012 Dr. Stathopoulos published a study on the application of Lipoplatin on patients with renal dysfunction. Usually patients with creatinine levels of 1.6 to 4.0 mg/dl or with a Glomerular Filtration Rate (GFR) of less than 60 ml/min cannot be treated with chemotherapy. In all oncology protocols one of the standard exclusion criteria is renal insufficiency (patients with creatinine levels above 1.6 mg/dl are excluded from all oncology protocols).
In the Stathopoulos study 42 patients mainly with lung and bladder cancers with renal insufficiency (creatinine levels 1.6 to 4.0 mg/ dl) were treated with Lipoplatin monotherapy or with its combination with gemcitabine, paclitaxel, or 5-fluorouracil- leucovorin. Whereas most chemotherapy regimens, especially those containing cisplatin, increase serum creatinine because of renal toxicity, Lipoplatin did not cause any increase in creatinine levels in any of the patients treated. Only Grade 1-2 myelotoxicity was observed which was mild and did not necessitate the use of growth factors. Complete response was observed in 5 patients with bladder cancer, partial response in 15 patients (8 with bladder, 2 with NSCLC and 5 with GI tract cancers) and stable disease was observed in 14 patients (3 with bladder, 6 with NSCLC and 5 with GI tract cancers). Only 8 of 42 patients had progressive disease (all 8 had NSCLC).
This work opens the possibility for the use of Lipoplatin in many cancer indications where patients have enhanced creatinine and urea levels either as a results of prior chemotherapy or because of renal insufficiency from other drugs or causes.
Regulon plans to request protocol assistance from EMA and seek registration of Lipoplatin for its application as monotherapy with low-dose radiation in a variety of cancers in patients with renal insufficiency.
In Regulon’s registrational EMA protocol to be completed with the help of key opinion leaders in oncology mainly from Austria, patients with renal insufficiency are defined as those with glomerular filtration rate (GFR) of less than 60 ml/min.
The % of patients in various cancer indications are:
- For urinary bladder cancer: ~40%
- For lung cancer: ~17% (from ESMO Open. 2016)
- For prostate cancer: 15% (ESMO Open. 2016)
- For breast cancer: 7% (ESMO Open. 2016)
- Gynecological cancers: 22% (ESMO Open. 2016)
- Colorectal: 17% (ESMO Open. 2016)
On the average, 15% of all cancer patients will be candidates for Lipoplatin after EMA approval in all indications
Levels of renal function in patients with cancer. CRC, colorectal cancer.
From: Launay-Vacher, Janus, and Deray. Renal insufficiency and cancer treatments ESMO Open. 2016; 1(4): e000091.