A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma
Abstract Background Cytoreductive nephrectomy is thought to improve survival in metastatic renal cell carcinoma (mRCC). As many patients are ineligible for major surgery, we hypothesized that SABR could be a safe alternative. Methods In this dose-escalation trial, inoperable mRCC patients underwent...
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BMC
2018-03-01
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| Series: | Radiation Oncology |
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| Online Access: | http://link.springer.com/article/10.1186/s13014-018-0992-3 |
| _version_ | 1819297926229262336 |
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| author | Rohann J. M. Correa Belal Ahmad Andrew Warner Craig Johnson Mary J. MacKenzie Stephen E. Pautler Glenn S. Bauman George B. Rodrigues Alexander V. Louie |
| author_facet | Rohann J. M. Correa Belal Ahmad Andrew Warner Craig Johnson Mary J. MacKenzie Stephen E. Pautler Glenn S. Bauman George B. Rodrigues Alexander V. Louie |
| author_sort | Rohann J. M. Correa |
| collection | DOAJ |
| description | Abstract Background Cytoreductive nephrectomy is thought to improve survival in metastatic renal cell carcinoma (mRCC). As many patients are ineligible for major surgery, we hypothesized that SABR could be a safe alternative. Methods In this dose-escalation trial, inoperable mRCC patients underwent SABR targeting the entire affected kidney. Toxicity (CTCAE v3.0), quality of life (QoL), renal function, and tumour response (RECIST v1.0) were assessed. Results Twelve patients of mostly intermediate (67%) or poor (25%) International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic class, median KPS of 70%, and median tumour size of 8.7 cm (range: 4.8–13.8) were enrolled in successive dose cohorts of 25 (n = 3), 30 (n = 6), and 35 Gy (n = 3) in 5 fractions. SABR was well tolerated with 3 grade 3 events: fatigue (2) and bone pain (1). QoL decreased for physical well-being (p = 0.016), but remained unchanged in other domains. SABR achieved a median tumour size reduction of − 17.3% (range: + 5.3 to − 54.4) at 5.3 months. All patients progressed systemically and median OS was 6.7 months. Crude median follow-up was 5.8 months. Conclusions In non-operable mRCC patients, renal-ablative SABR to 35 Gy in 5 fractions yielded acceptable toxicity, renal function preservation, and stable QoL. SABR merits further prospective investigation as an alternative to cytoreductive nephrectomy. Trial Registration ClinicalTrials.gov NCT02264548. Registered July 22 2014 – Retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT02264548 |
| first_indexed | 2024-12-24T05:21:46Z |
| format | Article |
| id | doaj.art-b7d9191ea461454c99367dea7b44ab7b |
| institution | Directory Open Access Journal |
| issn | 1748-717X |
| language | English |
| last_indexed | 2024-12-24T05:21:46Z |
| publishDate | 2018-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Radiation Oncology |
| spelling | doaj.art-b7d9191ea461454c99367dea7b44ab7b2022-12-21T17:13:27ZengBMCRadiation Oncology1748-717X2018-03-011311810.1186/s13014-018-0992-3A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinomaRohann J. M. Correa0Belal Ahmad1Andrew Warner2Craig Johnson3Mary J. MacKenzie4Stephen E. Pautler5Glenn S. Bauman6George B. Rodrigues7Alexander V. Louie8Department of Radiation Oncology, London Regional Cancer ProgramDepartment of Radiation Oncology, London Regional Cancer ProgramDepartment of Radiation Oncology, London Regional Cancer ProgramDepartment of Radiation Oncology, London Regional Cancer ProgramDepartment of Medical Oncology, London Regional Cancer ProgramDivision of Urology, Western UniversityDepartment of Radiation Oncology, London Regional Cancer ProgramDepartment of Radiation Oncology, London Regional Cancer ProgramDepartment of Radiation Oncology, London Regional Cancer ProgramAbstract Background Cytoreductive nephrectomy is thought to improve survival in metastatic renal cell carcinoma (mRCC). As many patients are ineligible for major surgery, we hypothesized that SABR could be a safe alternative. Methods In this dose-escalation trial, inoperable mRCC patients underwent SABR targeting the entire affected kidney. Toxicity (CTCAE v3.0), quality of life (QoL), renal function, and tumour response (RECIST v1.0) were assessed. Results Twelve patients of mostly intermediate (67%) or poor (25%) International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic class, median KPS of 70%, and median tumour size of 8.7 cm (range: 4.8–13.8) were enrolled in successive dose cohorts of 25 (n = 3), 30 (n = 6), and 35 Gy (n = 3) in 5 fractions. SABR was well tolerated with 3 grade 3 events: fatigue (2) and bone pain (1). QoL decreased for physical well-being (p = 0.016), but remained unchanged in other domains. SABR achieved a median tumour size reduction of − 17.3% (range: + 5.3 to − 54.4) at 5.3 months. All patients progressed systemically and median OS was 6.7 months. Crude median follow-up was 5.8 months. Conclusions In non-operable mRCC patients, renal-ablative SABR to 35 Gy in 5 fractions yielded acceptable toxicity, renal function preservation, and stable QoL. SABR merits further prospective investigation as an alternative to cytoreductive nephrectomy. Trial Registration ClinicalTrials.gov NCT02264548. Registered July 22 2014 – Retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT02264548http://link.springer.com/article/10.1186/s13014-018-0992-3Primary tumourRenal cellMetastaticStereotactic ablative radiotherapy |
| spellingShingle | Rohann J. M. Correa Belal Ahmad Andrew Warner Craig Johnson Mary J. MacKenzie Stephen E. Pautler Glenn S. Bauman George B. Rodrigues Alexander V. Louie A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma Radiation Oncology Primary tumour Renal cell Metastatic Stereotactic ablative radiotherapy |
| title | A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma |
| title_full | A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma |
| title_fullStr | A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma |
| title_full_unstemmed | A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma |
| title_short | A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma |
| title_sort | prospective phase i dose escalation trial of stereotactic ablative radiotherapy sabr as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma |
| topic | Primary tumour Renal cell Metastatic Stereotactic ablative radiotherapy |
| url | http://link.springer.com/article/10.1186/s13014-018-0992-3 |
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