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| The impact of chemotherapy-naïve open radical cystectomy delay and perioperative transfusion on the recurrence-free survival: A perioperative parameters-based nomogram |
Ahmed M. Harraz*( ),Ahmed Elkarta,Mohamed H. Zahran,Ahmed Mosbah,Atallah A. Shaaban,Hassan Abol-Enein
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| Urology and Nephrology Center, Mansoura University, Egypt |
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Abstract Objective: To develop and internally validate a nomogram to predict recurrence-free survival (RFS) including the time to radical cystectomy (RC) and perioperative blood transfusion (PBT) as potential predictors. Methods: Patients who underwent open RC and ileal conduit between January 1996 to December 2016 were split into developing (n=948) and validating (n=237) cohorts. The time to radical cystectomy (TTC) was defined as the interval between the onset of symptoms and RC. The regression coefficients of the independent predictors obtained by Cox regression were used to construct the nomogram. Discrimination, validation, and clinical usefulness in the validation cohort were assessed by the area under the curve, the calibration plot, and decision curve analysis. Results: In the developing dataset, the 1-, 5-, and 10-year RFS were 83.0%, 47.2%, and 44.4%, respectively. On multivariate analysis, independent predictors were TTC (hazards ratio [HR] 1.07, 95% confidence interval [CI] 1.05-1.08, p<0.001), PBT (one unit: HR 1.40, 95% CI 1.03-1.90, p=0.03; two or more units: HR 1.72, 95% CI 1.29-2.29, p<0.001), bilateral hydronephrosis (HR 1.54, 95% CI 1.21-1.97, p<0.001), squamous cell carcinoma (HR 0.60, 95% CI 0.45-0.81, p=0.001), pT3-T4 (HR 1.77, 95% CI 1.41-2.22, p<0.001), lymph node status (HR 1.53, 95% CI 1.21-1.95, p<0.001), and lymphovascular invasion (HR 1.28, 95% CI 1.01-1.62, p=0.044). The areas under the curve in the validation dataset were 79.3%, 69.6%, and 76.2%, for 1-, 5-, and 10-year RFS, respectively. Calibration plots showed considerable correspondence between predicted and actual survival probabilities. The decision curve analysis revealed a better net benefit of the nomogram. Conclusion: A nomogram with good discrimination, validation, and clinical utility was constructed utilizing TTC and PBT in addition to standard pathological criteria.
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Received: 30 April 2022
Available online: 20 April 2024
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Corresponding Authors:
* E-mail addresses: ahmed.harraz@hotmail.com,harraza@mans.edu.eg (A.M. Harraz).
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| Variable | Developing cohort (n=948) | Validating cohort (n=237) | Total (n=1185) | p-Value | | Age, year | 60.2±8.3 | 60.3±8.1 | 60.3±8.3 | 0.9 | | Albumin, g/dL | 3.5±0.5 | 3.5±0.4 | 3.5±0.5 | 0.4 | | BMI, kg/m2 | 27.6±4.8 | 27.9±5.2 | 27.6±4.9 | 0.4 | | Discharge eGFR, mL/min/1.73 m2 | 65.2±24.9 | 65.5±24.3 | 65.3±24.8 | 0.8 | | Hb, g/dL | 12.7±1.7 | 12.7±1.7 | 12.7±1.7 | 0.7 | | Platelet, x109/L | 273.5±105.3 | 277.8±102.3 | 274.4±104.7 | 0.5 | | TTC, weeks | 12 (4-12) | 12 (4-12) | 12 (4-12) | 0.4 | | Anemia | 0.6 | | No | 441 (46.5) | 115 (48.5) | 556 (46.9) | | | Yes | 507 (53.5) | 122 (51.5) | 629 (53.1) | | | PBT | 0.4 | | No | 182 (19.2) | 42 (17.7) | 224 (18.9) | | | One | 304 (32.1) | 69 (29.1) | 373 (31.5) | | | Two or more | 462 (48.7) | 126 (53.2) | 588 (49.6) | | | Albumin | 0.7 | | >3.5 g/dL | 430 (45.4) | 104 (43.9) | 534 (45.1) | | | ≤3.5 g/dL | 518 (54.6) | 133 (56.1) | 651 (54.9) | | | BMI | 0.7 | | <30 kg/m2 | 658 (69.4) | 161 (67.9) | 819 (69.1) | | | ≥30 kg/m2 | 290 (30.6) | 76 (32.1) | 366 (30.9) | | | Diabetes mellitus | 0.1 | | No | 807 (85.1) | 211 (89.0) | 1018 (85.9) | | | Yes | 141 (14.9) | 26 (11.0) | 167 (14.1) | | | Hypertension | 0.4 | | No | 759 (80.1) | 184 (77.6) | 943 (79.6) | | | Yes | 189 (19.9) | 53 (22.4) | 242 (20.4) | | | CCI | 0.1 | | I | 767 (80.9) | 184 (77.6) | 951 (80.3) | | | II | 167 (17.6) | 45 (19.0) | 212 (17.9) | | | III | 14 (1.5) | 8 (3.4) | 22 (1.9) | | | Gender | 0.4 | | Male | 758 (80.0) | 195 (82.3) | 953 (80.4) | | | Female | 190 (20.0) | 42 (17.7) | 232 (19.6) | | | Smoking | 0.2 | | Never | 308 (32.5) | 75 (31.6) | 383 (32.3) | | | Former | 112 (11.8) | 37 (15.6) | 149 (12.6) | | | Current | 528 (55.7) | 125 (52.7) | 653 (55.1) | | | Solitary kidney | 0.8 | | No | 756 (79.7) | 191 (80.6) | 947 (79.9) | | | Yes | 192 (20.3) | 46 (19.4) | 238 (20.1) | | | Hydronephrosis | 0.3 | | No | 420 (44.3) | 118 (49.8) | 538 (45.4) | | | Unilateral | 312 (32.9) | 72 (30.4) | 384 (32.4) | | | Bilateral | 216 (22.8) | 47 (19.8) | 263 (22.2) | | | History of NMIBC | 0.04 | | No | 842 (88.8) | 198 (83.5) | 1040 (87.8) | | | Yes | 106 (11.2) | 39 (16.5) | 145 (12.2) | | | Cell type | 0.4 | | UC | 705 (74.4) | 170 (71.7) | 875 (73.8) | | | SCC | 175 (18.5) | 53 (22.4) | 228 (19.2) | | | Adeno | 33 (3.5) | 8 (3.4) | 41 (3.5) | | | Others | 35 (3.7) | 6 (2.5) | 41 (3.5) | | | Positive lymph node | 0.9 | | No | 653 (68.9) | 162 (68.4) | 815 (68.8) | | | Yes | 295 (31.1) | 75 (31.6) | 370 (31.2) | | | LVI | | No | 640 (67.5) | 165 (69.6) | 805 (67.9) | 0.5 | | Yes | 308 (32.5) | 72 (30.4) | 380 (32.1) | | | pT | | T1-T2 | 425 (44.8) | 113 (47.7) | 538 (45.4) | 0.4 | | T3-T4 | 523 (55.2) | 124 (52.3) | 647 (54.6) | | | High-grade POC | | No | 874 (92.2) | 214 (90.3) | 1088 (91.8) | 0.4 | | Yes | 74 (7.8) | 23 (9.7) | 97 (8.2) | | | Distant metastasis | | No | 735 (77.5) | 188 (79.3) | 923 (77.9) | 0.6 | | Yes | 213 (22.5) | 49 (20.7) | 262 (22.1) | | | Local recurrence | | No | 690 (72.8) | 181 (76.4) | 871 (73.5) | 0.3 | | Yes | 258 (27.2) | 56 (23.6) | 314 (26.5) | | | Follow-up, month | 31.5 (11.0-72.2) | 29 (11-72) | 31 (11-72) | 0.8 |
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The differences between the developing and validating cohorts in patients who underwent radical cystectomy and ileal conduit.
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| Variable | Univariate | Multivariate | | HR (95% CI) | p-Value | HR (95% CI) | p-Value | | Age, 10 yearsa | 1.18 (1.05-1.33) | 0.005 | - | -b | | TTC, week | 1.08 (1.06-1.09) | <0.001 | 1.07 (1.05-1.08) | <0.001 | | Anemia | | No | Reference | - | - | - | | Yes | 1.33 (1.10-1.62) | 0.004 | - | -b | | PBT | 0.001 | | No | Reference | - | - | | | One | 1.48 (1.09-2.00) | 0.01 | 1.40 (1.03-1.90) | 0.03 | | Two or more | 1.82 (1.37-2.42) | <0.001 | 1.72 (1.29-2.29) | <0.001 | | Hydronephrosis | 0.002 | | No | Reference | - | - | | | Unilateral | 1.30 (1.04-1.63) | 0.02 | 1.20 (0.95-1.51) | 0.1 | | Bilateral | 1.73 (1.36-2.20) | <0.001 | 1.54 (1.21-1.97) | <0.001 | | Cell type | 0.001 | | UC | Reference | - | - | | | SCC | 0.50 (0.38-0.66) | <0.001 | 0.60 (0.45-0.81) | 0.001 | | Adeno | 1.01 (0.60-1.69) | 0.9 | 1.09 (0.64-1.84) | 0.7 | | Others | 1.17 (0.71-1.94) | 0.5 | 1.58 (0.95-2.64) | 0.07 | | Positive LN | | No | Reference | - | - | - | | Yes | 2.38 (1.95-2.91) | <0.001 | 1.53 (1.21-1.95) | <0.001 | | LVI | | No | Reference | - | - | - | | Yes | 2.21 (1.81-2.70) | <0.001 | 1.28 (1.01-1.62) | 0.044 | | pT | | T1-T2 | Reference | - | - | - | | T3-T4 | 2.17 (1.78-2.66) | <0.001 | 1.77 (1.41-2.22) | <0.001 |
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Univariate and multivariate Cox regression model for factors associated with independent predictors of cancer-specific survival in patients underwent radical cystectomy.
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Kaplan-Meier survival curves for significant factors associated with recurrence-free survival in the developing set of patients who underwent radical cystectomy. (A) Hydronephrosis; (B) Histopathological diagnosis; (C) Perioperative blood transfusion (number of packed red blood cells transfused); (D) pT; (E) Lymphovascular invasion; (F) pN. p-Values were obtained by the log-rank test. UC, urothelial carcinoma; SCC, squamous cell carcinoma; pT, pathological tumor stage; pN, pathological lymph node; LVI?ve, negative lymphovascular invasion; LVI+ve, positive lymphovascular invasion; pN?ve, pathological negative lymph node; pN+ve, pathological positive lymph node.
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Nomogram to predict the probability of 1-, 5-, and 10-year RFS in patients who underwent radical cystectomy and ileal conduit. LN, lymph node; n, number of packed red blood cells; SCC, squamous cell carcinoma; pT, pathological tumor stage; RFS, recurrence-free survival.
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The validation dataset. (A-C) Calibration plot of the predicted probabilities of recurrence-free survival and the actual probabilities obtained by the Kaplan-Meier method: (A) 1 year; (B) 5 years; (C) 10 years. The closer the values to the diagonal line, the better the calibration. (D-F) Decision curve analysis depicting the net benefit against a range of threshold probabilities in comparison to treating-all or treating-none: (D) 1 year; (E) 5 years; (F) 10 years. AUC, area under the curve; CI, confidence interval.
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