About Adjuvant Therapy

Adjuvant therapy is treatment to prevent recurrence after surgery by eliminating metastases which are present at the time of surgery, but too small to detect. You're probably familiar with people with cancers like breast or colon cancer getting chemotherapy or radiation after surgery to remove the primary tumor. That's adjuvant therapy. For a more detailed introduction to adjuvant therapy, see Dr. Kevin Murphy's CancerGuide article, Understanding Adjuvant Therapy.

Many patients wonder if they should be getting some kind of adjuvant therapy after their nephrectomy, or even after they've been rendered free of detectable disease by surgery for metastatic disease. Unfortunately, there is no proven or standard adjuvant therapy for renal cell cancer.

Most patients are simply told that there is no adjuvant therapy, but actually although nothing is standard, there is a vaccine treatment which may be approved in Europe by early 2005, and there are also a few treatments in clinical trial. Very few patients are told about these things. Some of these treatments do have promise, and some are close to non-toxic, which is important if the evidence is thin and if you may already be cured anyway. Finding and taking part in such a trial is an opportunity to go beyond the standard advice, but there is no guarantee of benefit.

The higher your risk of recurrence, the more sense it makes to look for adjuvant treatment. If you had a higher stage or grade tumor, and particularly if you had positive lymph nodes, your risk of eventual recurrence is high. Also, adjuvant clinical trials for kidney cancer tend to require higher stage or larger tumors. If your tumor is small, the bad news is you probably don't qualify for adjuvant trials. The good news is you are very likely to be cured by surgery alone!

A Non-Toxic Vaccine with Promising Results

Clinical Trials and Clinical Trial Resources

• There Are Very Few Adjuvant Trials for Kidney Cancer... and because they aren't widely known, even to doctors, it will probably be up to you to search them out.
  
  
• All Adjuvant Trials Have a Time Limit Since Surgery: Most trials require you to sign up no later than 2-3 months past the date of surgery, a few allow as long as six. If it's been a long time since your surgery, you probably don't qualify for adjuvant trials.
  
  
• Some Adjuvant Trials Require You Sign Up Before Your Surgery: In particular, some trials require fresh tumor tissue to make an experimental vaccine.
  
  

Clinical Trial System

Clinical trials are run under a complex system with special rules. In order to choose a good trial, you need to understand how the system works so you can make it work for you. For in depth information, see my Strategic Guide to the Clinical Trial System. Though the system is complex, one important aspect applies to this situation: Most (but not all) adjuvant trials are randomized trials, and in most adjuvant trials for kidney cancer, the control group gets careful observation only, since observation is the best standard treatment.

Finding Trials

There are some superb resources on the net that make it easy to find cancer clinical trials:

• Don't expect to find a lot of trials. In my experience there are very few adjuvant trials for kidney cancer.
  
  
• Of specific interest, the Renal Cell Cancer Evaluated Trials Database is a small database of trials specifically for kidney cancer which is unique because the trials are actually researched and reviewed. (Disclosure: this is another one of my projects!). See the adjuvant trials section for detailed information on a few specific adjuvant trials.
  
  
• For a broader search, CancerGuide's list of Internet Clinical Trial Databases should set you on the right track.

Some Things Which Have Been Tried

In truth, few things have been tried as adjuvant therapy for renal cancer and there is nothing with clear proof of efficacy. Several obvious choices such as Interferon [Pizzocaro 2001, Messing 2003] and High Dose Interleukin-2 [Clark 2003] have been tried without success (No randomized trial of outpatient IL-2 has yet been reported, although one is in progress - see clinical trial resources below).

References

Clark J, Atkins MB, Urba W, Figlin R, Dutcher JP, Flaherty L, Sosman J, Logan T, White R, Margolin K.

Adjuvant high-dose bolus interleukin-2 (HD IL-2) for patients (pts) with high-risk renal cell carcinoma (RCC) - a Cytokine Working Group randomized trial.

Proc Am Soc Clin Oncol (ASCO Meeting Abstract) 2003 22 : Abstract 659 [You can find this abstract on the ASCO website (I can't link directly because ASCO won't provide a stable URL)]

Comment: This randomized trial of adjuvant high dose IL-2 offered an extreme difference between treatments for patients with high risk RCC, high dose IL-2 versus observation only, and it accrued very slowly. The trial was stopped as less than the planned accrual when an interim analysis showed that additional accrual would be very unlikely to change the results. Importantly, this trial also included patients with stage IV RCC who'd had all known disease resected, as well as those with apparently localized disease who were at high risk for recurrence (stage III). No benefit for IL-2 was seen overall, or in either stage III or IV patients analyzed separately.

Both the abstract and Dr. Clark's slides (much more detail!) are available on the ASCO website.

Messing EM, Manola J, Wilding G, Propert K, Fleischmann J, Crawford ED, Pontes JE, Hahn R, Trump D.

Phase III study of interferon alfa-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern Cooperative Oncology Group/Intergroup trial.

J Clin Oncol. 2003 Apr 1;21(7):1214-22. [PubMed Abstract (will open in new window)]

Pizzocaro G, Piva L, Colavita M, Ferri S, Artusi R, Boracchi P, Parmiani G, Marubini E.

Interferon adjuvant to radical nephrectomy in Robson stages II and III renal cell carcinoma: a multicentric randomized study.

J Clin Oncol. 2001 Jan 15;19(2):425-31. [PubMed Abstract (will open in new window)]