To assess the safety, tolerability and efficacy of the CIMAvax (EGF vaccine) in Advance Non Small Cell Lung Cancer.
Patients with NSCLC Stage III and IV following the standard initial therapy was counseled and once consent was obtained were started on this program. Protocol was as follows 1 72 hours prior to the vaccination intravenous Cyclosphamide 300mg was given 2 On the day 0 patients are given 4 intramuscular injection of the vaccine, this is repeated on day 14, 28 and every 28days till disease progress. Patients are followed up till death.
A total of 23 patients from 1st September 2007 till 31st August 2014 received this treatment. The 1st 2 patients were part of a global Phase III Clinical trial and the other 21 were part of the Compassionate Program. There were 16 males and 7 females, 18 Malaysians, 2 Indonesian, 2 Australian and 1 from the Republic of China. Aged ranged from 28 to 77 years old with a mean of 56.04 and a median of 55 .18 patients had non squamous histology. One patient was Stage I who underwent surgery but relapsed 13 months later while the rest were all in the advance stage with 3 having brain metastasis. 3 out of 7 were positive for EGFR mutation. First line treatment were as following, 2 on Thyrosine kinase Inhibitors, 2 concurrent chemo radiotherapy, 4 chemotherapy followed by concurrent chemo radiotherapy and 15 chemotherapy. A total of 112 vaccinations with a median of 11 and a mean of 4.9 were noted. Overall survival ranged from 6 to 92 months with a median of 21months and a mean of 30.2 months.4 patients are still alive (34months, 38 months, 40months and 90months respectively). We loss contact on month 43 with the patient from the Republic of China. Survival rates at 91% (12 months), 43% (24months), 30% (36 months) and 9% (60months). Pain and chills with rigors was the most common side effect.
CIMAvax was well tolerated.It is unique as in our patients the treatment worked well in the squamous as well as non squamous patients. Presence of EGF mutation did not affect the outcome. Since more than 90% of the patients lived more than 12 months and close to half lived close to 24months clearly shows this vaccine will have to be investigated in larger Phase III trials to confirm it's efficacy.
Clinical trial identification
All authors have declared no conflicts of interest.