Post-operative kidney cancer patients show no increased recurrence-free survival (RFS) when given the new vitespen vaccine. However a possible improvement in RFS in patients with early stage disease given this vaccine needs further investigation. These are the conclusions of authors of an Article published early Online and in an upcoming edition of The Lancet.
Standard treatment of renal cell carcinoma (kidney cancer) involves surgery. However, a high proportion of patients are at risk of recurrence because no effective adjuvant treatment exists. Dr Christopher Wood, M D Anderson Cancer Center, Houston, TX, USA, and colleagues investigated the efficacy of a new vaccine, vitespen, as an adjuvant therapy to surgery in a randomised phase III trial.
Patients were randomised to receive either vitespen (409) or observation (409) after surgery. Vitespen was given intradermally once a week for four weeks, then every two weeks until vaccine depletion. A number of patients were excluded from the final analysis as they did not meet post-surgery inclusion criteria; thus analysis was completed on 361 patients in the vitespen group and 367 in the observation group.
The researchers found no significant difference in recurrence-free survival between the two groups. When the sub-group of patients with stage I or II renal cell carcinoma were analysed separately, recurrence events occurred in 15.2% of these patients receiving vitespen and 27.0% of those receiving observation alone â€" ie, those receiving vitespen were around half as likely to experience recurrence. However, this finding was not statistically significant.
The authors conclude: "No difference in recurrence-free survival was seen between patients given vitespen and those who received no treatment after surgery for renal cell carcinoma. A possible improvement in recurrence-free survival in patients with early stage disease who received vitespen will require further validation."
In an accompanying Comment, Dr James Yang, National Cancer Institute, Bethesda, MD, USA discusses how the field of cancer immunotherapy is weakened when some investigators, and particularly vaccine companies, cannot accept the results of randomised clinical studies. He comments on how the manufacturers of vitepsen have focused on one possible positive outcome rather than the overall negative outcome of the study. He says: "Such practices are akin to shooting the arrow first and being permitted to draw the target afterwards."
He also raises concerns over the content of a press release issued by manufacturers of vitespen, which, despite the results of this trial in The Lancet, promoted the approval of vitespen in Russia for patients with intermediate risk renal cancer. He concludes: "Commercially driven efforts that spin or obfuscate the conclusions of such a trial should be vigorously resisted because such efforts severely erode its value."
Dr Christopher Wood, M D Anderson Cancer Center, Houston, TX, USA T) +1 713-563-7476 / +1 713-563-7463 E) cgwood@mdanderson.org
Dr James Yang, National Cancer Institute, Bethesda, MD, USA T) +1 301-496-1574 E) jamesyang@mail.nih.gov
http://www.eurekalert.org/jrnls/lance/pdfs/kidneyvaccine.pdf
Journal
The Lancet