Nephrotoxicity Associated with Cytoreductive Surgery Combined with Cisplatin-Based Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Malignant Disease: A Systematic Review and Meta-Analysis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Data Collection
2.2. Eligibility Criteria
2.3. Study Selection and Data Extraction
2.4. Outcome Measures
2.5. Statistical Analysis
2.6. Methodological Quality of the Included Studies and Risk of Bias Assessment
3. Results
3.1. Characteristics of Included Studies
3.2. Assessment of Risk of Bias
3.3. Quantitative Synthesis
Primary Endpoint: Incidence of Acute and Chronic Renal Impairment
4. Discussion
Strengths and Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Study characteristics | Type of study: observational studies, either prospective or retrospective, randomized and non-randomized clinical trials. |
Unicentric or multicentric. | |
Year of publication. | |
Population | Number of patients included. |
Number of study arms and their distribution based on HIPEC protocol and nephroprotective usage. | |
Gender distribution: male or female. | |
Age. | |
Previous chronic renal disease (yes/no). | |
Previous chemotherapy: cisplatin, other drugs, non-stated. | |
Renal injury predisposing factors: ACE * inhibitors and angiotensin II receptor inhibitors, diabetes, hypertension. | |
Etiology of PSM: ovarian or other. | |
HIPEC | HIPEC drugs: cisplatin or cisplatin + doxorubicin. |
Perfusate volume: fixed volumes or body surface area-based volume. | |
Dosage: ≤50 mg/m2; 50–75 mg/m2; 75–100 mg/m2; ≥100 mg/m2. | |
Duration (minutes). | |
Temperature (Celsius). | |
Open or closed technique. | |
Nephroprotective strategy: sodium thiosulphate (ST), amifostine, no. | |
Kidney injury | Incidence of acute kidney injury. |
Acute kidney injury classification: RIFLE, KDIGO, AKIN, WHO, Clavien–Dindo, CTCAE. | |
Incidence of chronic kidney disease. |
Study | Country | Study Design | Treatment | Nephroprotector | Sample Size | Cases of Renal Impairment | Previous CKD | Tumor Etiology | Cisplatin Dose | HIPEC Duration (Minutes) | Renal Impairment Scale |
---|---|---|---|---|---|---|---|---|---|---|---|
Martina 2019 [122] | France | Cohort | Cisplatin | No | 66 | 30 | No | Ovary | 50–100 mg/m2 | 60 min | RIFLE |
Laplace 2020T [6] | France | Cohort | Cisplatin | Yes (ST) | 73 | 11 | Yes | Various | 50–100 mg/m2 | 60–90 min | WHO |
Lim 2007 [123] | USA | Non-randomized clinical trial | Cisplatin | Yes (amifostine) | 19 | 7 | No | Various | 90 mg/m2 * | 90 min | CTCAE |
Nizri 2018 [124] | Italy | Cohort | Cisplatin and doxorubicin | No | 19 | 2 | N/A | N/A | 42.5 mg/L + 15.2 mg/L ** | 90 min | CTCAE |
Sin 2017 [125] | Singapore | Cohort | Cisplatin | No | 47 | 19 | N/A | Ovary | 90 mg/m2 | 60 min | CTCAE |
Somashekhar 2019T [118] | India | Cohort | Both | No | 114 | 7 | N/A | Various | 75–100 mg/m2 # 40 + 15 mg/m2 ** | 90 min | CTCAE |
Tan 2017 [126] | Singapore | Cohort | Cisplatin | No | 92 | 32 | No | Various | 40 mg/body surface | 60 min | CTCAE |
Warschkow 2012 [127] | Switzerland | Cohort | Cisplatin | No | 21 | 2 | Yes | Ovary | 50 mg/m2 $ | 90 min | N/A |
Cata 2018 [128] | USA | Cohort | Cisplatin | No | 81 | 29 | No | N/A | Not-stated | N/A | AKIN |
Chan 2021 [129] | China | Non-randomized clinical trial | Cisplatin | No | 30 | 7 | N/A | Various | 70 mg/m2, 75 mg/m2, 80 mg/m2 and 85 mg/m2 & | 60 min | CTCAE |
Friedrich 2020 [130] | Germany | Case series | Cisplatin | No | 42 | 2 | N/A | Ovary | 50 mg/m2 | 90 min | CLAVIEN DINDO |
Alonso 2022 [7] | Australia | Case-control | Cisplatin | Yes (ST) | 10 | 4 | No | Various | 100 mg/m2 % | 90 min | RIFLE |
D’Hondt 2016 [131] | Belgium | Non-randomized clinical trial | Cisplatin | No | 16 | 1 | No | Ovary | 50 mg/m2 | 60 min | CTCAE |
Liesenfeld 2023 T [117] | Germany | Cohort | Both | No | 56 | 37 | N/A | Various | 75 mg/m2 % 50 mg/m2 + 15 mg/m2 ** 50 mg/m2 + 15 mg/m2 ** + EPIC | 90 min | KDIGO |
Rihuete-Caro 2018 [132] | Spain | Cohort | Cisplatin and adriamicine | No | 35 | 1 | N/A | N/A | 100 mg/m2 + 15 mg/m2 ** | 90 min | RIFLE |
Chatzigeorgiou 2003 [133] | Greece | Non-randomized clinical trial | Cisplatin | Yes (amifostine) | 20 | 2 | N/A | Ovary | 50–70 mg/m2 # | 120 min | CTCAE |
Lim 2022 T [119] | South Korea | Randomized clinical trial | Cisplatin | Yes (amifostine) | 92 | 21 | N/A | Ovary | 75 mg/m2 | 90 min | CTCAE |
Glennon 2021 T [121] | Ireland | Case-control | Cisplatin | Yes (ST) | 30 | 1 | No | Ovary | 50 mg/m2 100 mg/m2 | 90 min | KDIGO |
Raj 2021 [134] | India | Non-randomized clinical trial | Cisplatin | No | 15 | 0 | N/A | Ovary | 75 mg/m2 | 60 min | CLAVIEN DINDO |
Bondar 2021 [135] | Ukraine | Cohort | Cisplatin and adriamicine | Yes (ST) | 57 | 8 | N/A | Various | 50 mg/m2 + 15 mg/m2 ** | 90 min | CLAVIEN DINDO |
Carias 2022 [136] | Portugal | Cohort | Cisplatin | No | 42 | 11 | N/A | Various | 50 mg/m2 | 90 min | KDIGO |
Bai 2023 [137] | China | Cohort | Cisplatin | No | 282 | 33 | N/A | Ovary | 50 to 80 mg/m2 | 60 min | KDIGO |
Senguttuvan 2023 T [120] | USA | Non-randomized clinical trial | Cisplatin | Yes (ST) | 40 | 6 | N/A | Various | 75 mg/m2 | 60 min | CTCAE |
Chen 2021 [58] | Australia | Cohort | Cisplatin | No | 59 | 4 | N/A | Various | 100 mg/m2 % | 90 min | RIFLE |
Gomez-Ruiz 2021 [138] | Spain | Cohort | Cisplatin | No | 62 | 14 | N/A | Ovary | 75 mg/m2 | 60 min | RIFLE |
Hakeam 2014 [139] | Saudi Arabia | Cohort | Cisplatin and adriamicine | No | 53 | 2 | Yes | Various | 50 mg/m2 + 15 mg/m2 ** | 90 min | RIFLE |
(A) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Study | JBc1 | JBc2 | JBc3 | JBc4 | JBc5 | JBc6 | JBc7 | JBc8 | JBc9 | JBc10 | JBc11 | % Yes | Risk | ||
Martina 2019 [122] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Laplace 2020 [6] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | -- | 91 | Low | ||
Nizri 2018 [124] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Sin 2017 [125] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Somashekhar 2019 [118] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | -- | 91 | Low | ||
Tan 2017 [126] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Warschkow 2012 [127] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | U | ✓ | ✓ | ✓ | ✓ | 91 | Low | ||
Cata 2018 [129] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | U | ✓ | 91 | Low | ||
Liesenfeld 2023 [117] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Rihuete-Caro 2018 [132] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | U | ✓ | ✓ | ✓ | ✓ | 91 | Low | ||
Bondar 2021 [135] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Carias 2022 [136] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Bai 2023 [137] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | U | U | ✓ | 82 | Low | ||
Chen 2021 [58] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | U | U | ✓ | 82 | Low | ||
Gomez-Ruiz 2021 [138] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | ||
Hakeam 2014 [139] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | U | U | ✓ | 82 | Low | ||
(B) | |||||||||||||||
Study | JBcc1 | JBcc2 | JBcc3 | JBcc4 | JBcc5 | JBcc6 | JBcc7 | JBcc8 | JBcc9 | JBcc10 | % Yes | Risk | |||
Alonso 2022 [7] | ✓ | ✓ | ✓ | ✓ | ✓ | -- | -- | ✓ | ✓ | -- | 70 | Low | |||
Glennon 2021 [123] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | -- | 90 | Low | |||
(C) | |||||||||||||||
Study | JBcs1 | JBcs2 | JBcs3 | JBcs4 | JBcs5 | JBcs6 | JBcs7 | JBcs8 | JBcs9 | JBcs10 | % Yes | Risk | |||
Friedrich 2020 [130] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 100 | Low | |||
(D) | |||||||||||||||
Study | JBrct1 | JBrct2 | JBrct3 | JBrct4 | JBrct5 | JBrct6 | JBrct7 | JBrct8 | JBrct9 | JBrct10 | JBrct11 | JBrct12 | JBrct13 | % Yes | Risk |
Lim 2022 [119] | ✓ | ✓ | ✓ | ✓ | -- | U | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 85 | Low |
(E) | |||||||||||||||
Study | JBnrct1 | JBnrct2 | JBnrct3 | JBnrct4 | JBnrct5 | JBnrct6 | JBnrct7 | JBnrct8 | JBnrct9 | % Yes | Risk | ||||
Lim 2007 [123] | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | -- | 89 | Low | ||||
Chan 2021 [129] | ✓ | ✓ | ✓ | -- | ✓ | ✓ | ✓ | ✓ | ✓ | 89 | Low | ||||
D’Hondt 2016 [131] | ✓ | ✓ | ✓ | -- | -- | ✓ | ✓ | ✓ | -- | 67 | Moderate | ||||
Chatzigeorgiou 2003 [133] | ✓ | U | U | -- | ✓ | ✓ | ✓ | ✓ | ✓ | 67 | Moderate | ||||
Raj 2021 [134] | ✓ | U | U | -- | ✓ | ✓ | ✓ | ✓ | ✓ | 67 | Moderate | ||||
Senguttuvan 2023 [120] | -- | ✓ | -- | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 78 | Low | ||||
Gouy 2016 [27] | ✓ | ✓ | ✓ | -- | -- | ✓ | ✓ | ✓ | ✓ | 78 | Low |
Subgroup by Study Characteristics | Nº of Studies | Participants | Effect Size and 95% Interval * | Heterogeneity I2 | p Value | ||
---|---|---|---|---|---|---|---|
AKI Incidence | Lower Limit | Upper Limit | |||||
1473 | |||||||
Nephroprotector 1 | 0.194 | ||||||
Yes | 8 | 208 | 11.5% | 4.9% | 25,0% | 65.0% | |
No | 24 | 1265 | 20.5% | 14.5% | 28.0% | 84.8% | |
Nephroprotector 2 | 0.362 | ||||||
Amifostine | 3 | 60 | 14.0% | 2.9% | 46.9% | 71.2% | |
Sodium thiosulphate | 5 | 148 | 8.8% | 2.5% | 27.0% | 65.8% | |
No nephroprotector | 24 | 1265 | 20.5% | 14.5% | 28.0% | 84.8% | |
HIPEC | 0.432 | ||||||
Cisplatin | 26 | 1261 | 20.2% | 14.6% | 27,2% | 81.3% | |
Cisplatin and adriamicine | 6 | 212 | 12.5% | 3.5% | 36.0% | 87.7% | |
Cisplatin dose | 0.411 | ||||||
≤50 mg/m2 | 6 | 243 | 12.5% | 6.8% | 2.8% | 75.3% | |
>50–75 mg/m2 | 2 | 302 | 11.6% | 8.4% | 15.7% | 0.0% | |
75–100 mg/m2 | 13 | 519 | 18.8% | 11.7% | 28.9% | 77.0% | |
≥100 mg/m2 | 5 | 165 | 12.9% | 4.1% | 33.7% | 79.5% | |
HIPEC duration | 0.465 | ||||||
60 min | 10 | 650 | 23.2% | 14.4% | 35.0% | 84.40% | |
60–90 min | 2 | 73 | 9.1% | 0.3% | 76.1% | 83.0% | |
90 min | 18 | 649 | 15.2% | 8.7% | 25.3% | 83.7% | |
120 min | 1 | 20 | 10.0% | 2.5% | 32.4% | 0.0% | |
Renal impairment scale | 0.005 | ||||||
AKIN | 1 | 81 | 35.8% | 26.1% | 46.8% | 0.0% | |
CLAVIEN DINDO | 3 | 114 | 8.8% | 3.6% | 20% | 32.1% | |
CTCAE | 15 | 499 | 17.8% | 11.6% | 26.3% | 70.4% | |
KDIGO | 4 | 380 | 38.8% | 13.1% | 72.7% | 95.3% | |
RIFLE | 6 | 285 | 15.4% | 6.1% | 33.8% | 86.8% | |
WHO | 2 | 73 | 9.1% | 0.4% | 76.1% | 83% | |
Tumor origin | 0.358 | ||||||
Ovary | 13 | 693 | 15.5% | 9.2% | 25.1% | 82.0% | |
Various | 16 | 645 | 21.3% | 13.35 | 32.4% | 83.8% | |
Previous kidney disease | 0.036 | ||||||
No | 8 | 314 | 33.9% | 25.3% | 43.6% | 47.9% | |
Yes | 4 | 147 | 8.4% | 1.9% | 30.2% | 79.6% | |
Sex distribution (Woman %) | 0.259 | ||||||
≤50% | 3 | 111 | 26.8% | 12.9% | 47.6% | 56.2% | |
50–75% | 5 | 190 | 30.2% | 11.4% | 59.4% | 90.0% | |
>75% | 21 | 977 | 16.0% | 10.7% | 23.1% | 79.5% | |
Age distribution | 0.268 | ||||||
≤60 years | 19 | 641 | 18.0% | 12.3% | 25.6% | 71.3% | |
>60 years | 6 | 421 | 31.4% | 11.9% | 61.0% | 93% |
Scale | Creatinine Criteria | Urine Output Criteria |
---|---|---|
RIFLE | ||
R (Risk) | Serum creatinine increase 1.5-fold or GFR > 25% from baseline | <0.5 mL/kg/h for 6 h |
I (Injury) | Serum creatinine increase 2.0-fold or GFR > 50% from baseline | <0.5 mL/kg/h for 12 h |
F (Failure) | Serum creatinine increase 3.0-fold or GFR > 75% from baseline or serum creatinine > 4.0 mg/dL with an acute increase of at least 0.5 mg/dL | Anuria for 12 h |
AKIN | ||
1 | Serum creatinine increase 0.3 mg/dL or increase to 1.5–2.0 fold from baseline | <0.5 mL/kg/h for 6 h |
2 | Serum creatinine increase > 2.0–3.0 fold from baseline | <0.5 mL/kg/h for 12 h |
3 | Serum creatinine increase > 3.0 fold from baseline or serum creatinine ≥ 4.0 mg/dL with an acute increase of at least 0.5 mg/dL or need for renal replacement therapy | <0.3 mL/kg/h for 24 h or anuria for 12 h or need for renal replacement therapy |
KDIGO | ||
1 | Serum creatinine increase 1.5–1.9 times baseline or ≥0.3 mg/dL within 48 h | <0.5 mL/kg/h for 6–12 h |
2 | Serum creatinine increase 2.0–2.9 times baseline | <0.5 mL/kg/h for ≥12 h |
3 | Serum creatinine increase 3.0 mg/dL times baseline or increase ≥ 4.0 mg/dL or initiation of renal replacement therapy | <0.3 mL/kg/h for 24 h or anuria for ≥12 h |
CTCAE v. 5.0. (Acute kidney injury) | ||
Grade 1 | - | - |
Grade 2 | - | - |
Grade 3 | Hospitalization indicated | - |
Grade 4 | Life-threatening consequences; dialysis indicated | - |
CTCAE (Creatinine increase) | ||
Grade 1 | Creatinine increased > upper limit normal (ULN)-1.5 × ULN | - |
Grade 2 | Creatinine increased > 1.5–3.0 × baseline; >1.5–3.0 × ULN | - |
Grade 3 | Creatinine increased > 3.0 × baseline; 3.0–6.0 × ULN | - |
Grade 4 | Creatinine increased > 6.0 × ULN | - |
Clavien–Dindo | ||
Grade I | Any deviation from the normal postoperative course without the need for pharmacological treatment, or surgical, endoscopic, and radiological interventions Allowed therapeutic regimens are drugs including antiemetics, antipyretics, analgesics, and diuretics and electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside | - |
Grade II | Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included | - |
Grade III | Requiring surgical, endoscopic, or radiological intervention
| - |
Grade IV | Life-threatening complication (including central nervous system complications) requiring IC/ICU management
| - |
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Grillo-Marín, C.; Antón-Rodríguez, C.; Prieto, L.; Ortega-Pérez, G.; González-Moreno, S. Nephrotoxicity Associated with Cytoreductive Surgery Combined with Cisplatin-Based Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Malignant Disease: A Systematic Review and Meta-Analysis. J. Clin. Med. 2024, 13, 3793. https://doi.org/10.3390/jcm13133793
Grillo-Marín C, Antón-Rodríguez C, Prieto L, Ortega-Pérez G, González-Moreno S. Nephrotoxicity Associated with Cytoreductive Surgery Combined with Cisplatin-Based Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Malignant Disease: A Systematic Review and Meta-Analysis. Journal of Clinical Medicine. 2024; 13(13):3793. https://doi.org/10.3390/jcm13133793
Chicago/Turabian StyleGrillo-Marín, Cristián, Cristina Antón-Rodríguez, Lola Prieto, Gloria Ortega-Pérez, and Santiago González-Moreno. 2024. "Nephrotoxicity Associated with Cytoreductive Surgery Combined with Cisplatin-Based Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Malignant Disease: A Systematic Review and Meta-Analysis" Journal of Clinical Medicine 13, no. 13: 3793. https://doi.org/10.3390/jcm13133793
APA StyleGrillo-Marín, C., Antón-Rodríguez, C., Prieto, L., Ortega-Pérez, G., & González-Moreno, S. (2024). Nephrotoxicity Associated with Cytoreductive Surgery Combined with Cisplatin-Based Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Malignant Disease: A Systematic Review and Meta-Analysis. Journal of Clinical Medicine, 13(13), 3793. https://doi.org/10.3390/jcm13133793