2018 ASCO: Carmena Trial Compares Nephrectomy Plus Adjuvant Sunitinib vs Sunitinib Alone in Metastatic RCC

Key Points

  • Survival was not worse with sunitinib alone than with surgery and sunitinib. This was true for the study population as a whole (median survival was 18.4 months without surgery vs 13.9 months with surgery), as well as for subgroups with an intermediate prognosis (median survival was 23.4 months vs 19 months) and a poor prognosis (median survival was 13.3 months vs 10.2 months).
  • The rate of tumor response to therapy was the same in the two treatment groups (27.4% and 29.1%), and the median time until the cancer worsened was slightly longer for patients who received sunitinib alone than for those who also had surgery (8.3 months vs 7.2 months).
  • Clinical benefit was experienced by 47.9% of patients treated with sunitinib alone, compared with 36.6% of patients treated with surgery and sunitinib.

The randomized phase III Carmena trial showed that many people with advanced kidney cancer can avoid nephrectomy without compromising survival. The median overall survival for people who received the targeted therapy sunitinib (Sutent) alone was 18.4 months, compared with 13.9 months for those who received surgery followed by sunitinib, the current standard of care.

These findings were presented by Mejean et al in ASCO’s Plenary Session, which features four studies deemed to have the greatest potential impact on patient care featured as part of the 2018 ASCO Annual Meeting (Abstract LBA3).

“Until now, nephrectomy has been considered the standard of care for patients with kidney cancer who have metastatic disease when the cancer is first diagnosed. These cases account for about 20% of all kidney cancers worldwide,” said lead study author Arnaud Mejean, MD, a urologist at the Department of Urology, Hôpital Européen Georges-PompidouParis Descartes University in Paris, France. “Our study is the first to question the need for surgery in the era of targeted therapies and clearly shows that surgery for certain people with kidney cancer should no longer be the standard of care.”

In addition to putting patients at risk for complications, including blood loss, infection, pulmonary embolism, and heart problems, nephrectomy delays medical treatment for weeks in people with advanced kidney cancer. In some cases, the cancer worsens so rapidly during this delay that there is no time to start systemic treatment.

About the Study

The Carmena trial enrolled 450 patients with synchronous metastatic renal cell carcinoma. An estimated 40,000 to 50,000 people each year are diagnosed with this type of cancer.

The patients were randomly assigned to receive surgery followed by sunitinib or sunitinib alone. In the surgery group, patients started sunitinib 4 to 6 weeks after surgery to allow time for recovery from surgery.

Key Findings

Patients were followed for a median time of 50.9 months. Survival was not worse with sunitinib alone than with surgery and sunitinib. This was true for the study population as a whole (median survival was 18.4 months without surgery vs 13.9 months with surgery), as well as for subgroups with an intermediate prognosis (median survival was 23.4 months vs 19 months) and a poor prognosis (median survival was 13.3 months vs 10.2 months).

The difference in median survival seems to suggest a greater benefit with sunitinib alone. However, this cannot be concluded, as this trial was not designed to prove that one treatment is superior to the other, noted Dr. Mejean.

The rate of tumor response to therapy was the same in the two treatment groups (27.4% and 29.1%), and the median time until the cancer worsened was slightly longer for patients who received sunitinib alone compared with those who also had surgery (8.3 months vs 7.2 months). Clinical benefit was experienced by 47.9% of patients treated with sunitinib alone, compared with 36.6% of patients treated with surgery and sunitinib.

The authors remarked that nephrectomy is still the gold standard for people who do not need systemic therapy, such as those with just one metastasis. Those patients were not included in this clinical trial.

Next Steps

Some patients in the study had a very good response to sunitinib alone and received surgery after completing systemic treatment. The researchers plan to continue following the outcomes in these patients, as well as in other subgroups of study participants. Genomic research on tumor tissue collected on the study is under way.

Commentary

“Thanks to this research, many patients with advanced kidney cancer can be spared unnecessary surgery and a host of severe side effects that often accompany it. These findings will likely lead to a dramatic change in treatment for people who are diagnosed with metastatic kidney cancer,” said ASCO Expert Sumanta K. Pal, MD.

This study received funding from PHRC (French governmental grants for clinical research).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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