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Durable complete response for oligometastatic renal cell carcinoma with immune checkpoint inhibition and cytoreductive nephrectomy in a Jehovah's witness: A case report.

ABSTRACT: The role of cytoreductive nephrectomy in patients with metastatic renal cell carcinoma is a subject of debate. We report a durable complete response in a 62-year-old man Jehovah's Witness with metastatic clear cell renal cell carcinoma who received two cycles of nivolumab/ipilimumab followed by radical nephrectomy and metastasectomy of known pulmonary disease site, both without a clinical need for perioperative blood transfusions. The patient continues to be without evidence of disease and without additional need for systemic therapy over a year after his radical nephrectomy. The case highlights that cytoreductive nephrectomy continues to play a role in the era of immune checkpoint inhibitors.

SUBMITTER: Zhuang TZ

PROVIDER: S-EPMC9755666 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Durable complete response for oligometastatic renal cell carcinoma with immune checkpoint inhibition and cytoreductive nephrectomy in a Jehovah's witness: A case report.

Zhuang Tony Zibo TZ Harik Lara L Force Seth S Hadadi Agreen A Bilen Mehmet Asim MA Brown Jacqueline T JT Carthon Bradley C BC Goldman Jamie J Kucuk Omer O Master Viraj A VA Nazha Bassel B

Frontiers in oncology 20221202

The role of cytoreductive nephrectomy in patients with metastatic renal cell carcinoma is a subject of debate. We report a durable complete response in a 62-year-old man Jehovah's Witness with metastatic clear cell renal cell carcinoma who received two cycles of nivolumab/ipilimumab followed by radical nephrectomy and metastasectomy of known pulmonary disease site, both without a clinical need for perioperative blood transfusions. The patient continues to be without evidence of disease and witho ...[more]

PMID: 36530969

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Project description:IntroductionCurrent ethical practice allows for adult patients with decision-making capacity to refuse blood transfusion, even at the cost of high morbidity or mortality. However, for an adult patient who is of the Jehovah's Witness faith, an unwanted blood transfusion confers a psychospiritual cost to the patient and a financial cost to health care entities. The ethical boundaries are increasingly ambiguous with minors who are members of the Jehovah's Witness faith. This simulation experience intends to identify and address knowledge gaps in the care of minors in an emergent setting using a biomedical ethics framework.MethodsThis scenario provides an immersive simulation experience involving a 12-year-old Jehovah's Witness patient requiring emergent laparotomy for splenic hemorrhage. Patient interview (via simulation manikin with instructor voice) and care handoff take place in an operating room setting. The learner ascertains the patient's and family's refusal of blood products. Induction of general anesthesia results in profound patient hypotension secondary to acute blood-loss anemia. Pulseless electrical activity results if packed red blood cells are not administered. Ethical principles require the learner to impose an unwanted lifesaving therapy on a minor patient over the objections of family members. Secondly, the anesthesia provider must advocate for transfusion on these ethical grounds against a well-meaning but ultimately misguided surgeon who opposes transfusion. An included learner evaluation form based on ACGME core competencies facilitates postsimulation debriefing.ResultsParticipants were primarily anesthesia residents and fellows. Anecdotally, the residents said that it "felt good to be an attending" and that the simulation helped them appreciate how important conflict resolution skills are in the OR setting. Additionally, faculty appreciated the ability to assess the development of crucial assertiveness skills, with the option of remediating incorrect behavior during the debriefing.DiscussionThis simulation experience provides experience in the emergent medical management of a pediatric trauma patient while also incorporating specific ethical consent issues unique to pediatric and trauma patient populations. Furthermore, this experience develops professionalism skills and practice in assertive patient advocacy.

Project description:BackgroundRenal cell carcinoma (RCC) with sarcomatoid and/or rhabdoid (S/R) dedifferentiation is a highly aggressive tumor with a poor prognosis. Immune checkpoint therapy (ICT) has shown significant treatment efficacy in this subtype. There remains uncertainly regarding the role of cytoreductive nephrectomy (CN) for patients with metastatic RCC (mRCC) with S/R who received ICT.ObjectiveHere, we report the outcomes with ICT for patients with mRCC and S/R dedifferentiation by CN status.Design, setting, and participantsA retrospective review was conducted of 157 patients with sarcomatoid, rhabdoid, or sarcomatoid plus rhabdoid dedifferentiation who received an ICT-based regimen at two cancer centers.InterventionCN performed at any time point; nephrectomy with curative intent was excluded.Outcome measurements and statistical analysisICT treatment duration (TD) and overall survival (OS) from ICT initiation were recorded. To address the immortal time bias, a time-dependent Cox regression model was generated that accounted for confounders identified by a directed acyclic graph as well as a time-dependent nephrectomy variable.Results and limitationsA total of 118 patients underwent CN, and of them, 89 underwent upfront CN. The results did not contradict the supposition that CN does not improve ICT TD (hazard ratio [HR] 0.98, 95% confidence interval [CI] 0.65-1.47, p = 0.94) or OS from ICT initiation (HR 0.79, 95% CI 0.47-1.33, p = 0.37). In patients who underwent upfront CN compared with those who did not undergo CN, there was no association with ICT duration or OS (HR 0.61, 95% CI 0.35-1.06, p = 0.08). A detailed clinical summary of 49 patients with mRCC and rhabdoid dedifferentiation is provided.ConclusionsIn this multi-institutional cohort of mRCC with S/R dedifferentiation treated with ICT, CN was not significantly associated with improved TD or superior OS when accounting for the lead time bias. There appears to be a subset of patients who derive meaningful benefit from CN, so improved tools for stratification prior to CN are needed to optimize outcomes.Patient summaryImmunotherapy has improved outcomes for patients with metastatic renal cell carcinoma (mRCC) who have sarcomatoid and/or rhabdoid (S/R) dedifferentiation, which is an aggressive and uncommon feature; yet, the utility of a nephrectomy in this setting is unclear. We found that nephrectomy did not significantly improve survival or time on immunotherapy for these patients with mRCC and S/R dedifferentiation; yet, there may be a subset of patients who benefit from this surgical approach.

Project description:The Southwest Oncology Group (SWOG)1931 trial, also known as PROBE (ClinicalTrials.gov Identifier: NCT04510597) is a phase III study evaluating the role of cytoreductive nephrectomy (CN) in metastatic renal cell cancer (RCC). Kidney cancer presenting with synchronous metastases has demonstrated shorter survival outcome compared to the patients relapsing with metastases after nephrectomy. Previously, CN has been associated with survival improvement when interferon-based systemic therapy was used. In the setting of antivascular therapy sunitinib, a prospective randomized clinical trial demonstrated no benefit of CN. Immune checkpoint-based combination therapy has now become the standard-of-care in the frontline setting for RCC. The role of nephrectomy or primary resection has not been evaluated in the setting of immune checkpoint-based systemic therapy. The sequence and optimal timing of nephrectomy is also not established. The PROBE study design attempts to answer the question whether CN has an impact on overall survival outcomes in RCC within the context of immune checkpoint-based combination regimens. The study requires starting with systemic therapy; any one of the FDA approved immunotherapy-based regimens at the time the study was activated are permitted. The disease status and response are evaluated at 9-12 weeks of therapy and then consented patients are randomized 1:1 to receive CN or to continue systemic therapy. The patients who have rapid disease progression are considered ineligible for randomization as they need a switch in systemic therapy. Both groups should continue systemic therapy as long as they are tolerating the treatment and continuing to derive clinical benefit. Quality-of-life, tumor genomic testing, microbiome, radiomics and circulating tumor DNA assessments as predictive biomarkers are planned as study correlatives. The study hypothesis is that CN will improved OS in synchronous metastatic RCC when surgery is performed after starting systemic immune checkpoint-based combination therapy. A potential mechanism leading to improved survival is the broader antigen spread and higher neoantigen load enabled by the primary tumor enhancing the efficacy of the immune therapy. CN after initial systemic therapy would help select the patient subset most likely to benefit and will potentially enable eradication of immune resistant clones within the primary tumor.

Dataset Information

Durable complete response for oligometastatic renal cell carcinoma with immune checkpoint inhibition and cytoreductive nephrectomy in a Jehovah's witness: A case report.

Publications

Durable complete response for oligometastatic renal cell carcinoma with immune checkpoint inhibition and cytoreductive nephrectomy in a Jehovah's witness: A case report.

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