1National Network of Cancer Records. Instituto Nacional de Cancerología, Mexico City, Mexico
2Department of Clinical Research, Instituto Nacional de Cancerología, Mexico City, Mexico
3Consejo Nacional de Ciencia y Tecnología (CONACyT), Depatment of Clinical Research, Instituto Nacional de Cancerología, Mexico City, Mexico
4Hospital Regional No. 2 El Marques, Instituto Mexicano del Seguro Social, Queretaro, Mexico
5Research Unit in Metabolic Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
Copyright © 2022 by the Korean Cancer Association
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Ethical Statement
The local Ethics and Research Committees approved the study (No. 2019/0021). This is a retrospective study, approved by the Ethics and Research Comittees. For this retrospective study, the informed consent from the patient was not required. All the information used in this study was collected from the medical records. However, all patients that undergo cancer treatment at our Institution sign an infomed consent, in which they express their agreement to receive the treatment proposed by their physician.
Author Contributions
Conceived and designed the analysis: Cetina-Pérez L.
Collected the data: Brau-Figueroa H, Arango-Bravo E, Galicia-Carmona T, Abraham Lugo-Alferez L.
Contributed data or analysis tools: Brau-Figueroa H, Jiménez-Lima R.
Performed the analysis: Brau-Figueroa H, Arango-Bravo E, Castro-Eguiluz D.
Wrote the paper: Brau-Figueroa H, Arango-Bravo E, Castro-Eguiluz D.
Manuscript editing: Castro-Eguiluz D.
Guarantor of integrity of study: Cruz-Bautista I.
Conflicts of Interest
Conflict of interest relevant to this article was not reported.
Characteristic | Total patients (n=189) | Cisplatin (n=126) | Gemcitabine (n=63) | p-value |
---|---|---|---|---|
Age (yr)a) | 56.3±11.5 | 55.4±10.9 | 57.9±12.5 | 0.668b) |
Performance statusc) | ||||
ECOG 0 | 77 (40.7) | 47 (37.3) | 30 (47.6) | 0.348d) |
ECOG 1 | 107 (56.6) | 76 (60.3) | 31 (49.2) | |
ECOG 2 | 5 (2.6) | 3 (2.4) | 2 (3.2) | |
Clinical stagee) | ||||
IB2 | 12 (6.3) | 8 (6.3) | 4 (6.3) | 0.975d) |
IIA | 6 (3.2) | 4 (3.2) | 2 (3.2) | |
IIB | 108 (57.1) | 72 (57.1) | 36 (57.1) | |
IIIA | 1 (0.5) | 1 (0.8) | 0 | |
IIIB | 59 (31.2) | 39 (31.0) | 20 (31.7) | |
IVB | 3 (1.6) | 2 (1.6) | 1 (1.6) | |
Hemoglobin (g/dL) | 12.8±2.04 | 12.9±2.02 | 12.7±2.05 | 0.574b) |
Histology | ||||
Squamous cell carcinoma | 157 (83.1) | 102 (81.0) | 55 (87.3) | 0.536d) |
Adenocarcinoma | 23 (12.2) | 17 (13.5) | 6 (9.5) | |
Adenosquamous carcinoma | 9 (4.8) | 7 (5.6) | 2 (3.2) | |
Comorbidities | ||||
Number | 1.24±0.48 | 1.23±0.50 | 1.26±0.44 | 0.051b) |
Comorbidities=1 | 148 (78.3) | 102 (80.9) | 46 (73.9) | 0.212d) |
Comorbidities ≥ 2 | 41 (21.6) | 24 (19.0) | 17 (26.9) | |
T2DM | 89 (46.8) | 57 (45.2) | 32 (50.8) | < 0.001d) |
SAH | 112 (58.9) | 81 (64.3) | 31 (49.2) | |
Acute kidney injury | 19 (10.0) | 14 (11.1) | 5 (7.9) | |
Other | 15 (7.9) | 3 (2.4) | 12 (19.0) | |
Response ratesf) | ||||
Complete response | 165 (87.3) | 109 (86.5) | 56 (88.9) | 0.094d) |
Partial response | 9 (4.7) | 4 (3.2) | 5 (7.9) | |
Disease progression | 15 (7.9) | 13 (10.3) | 2 (3.2) | |
Pattern of failure | ||||
Local | 12 (6.3) | 7 (5.5) | 5 (7.9) | 0.917d) |
Locoregional | 9 (4.7) | 6 (4.7) | 3 (4.7) | |
Distant metastasis | 35 (18.5) | 22 (17.4) | 13 (20.6) | |
Locoregional+distant metastasis | 16 (8.4) | 14 (11.1) | 2 (3.1) | |
Persistent disease | 13 (6.8) | 10 (7.9) | 3 (4.7) |
Values are presented as mean±SD or number (%). SAH, systemic arterial hypertension; SD, standard deviation; T2DM, type 2 diabetes mellitus.
a) Kolmogorov-Smirnov test (normal distribution is assumed),
b) Student T test for independent samples,
c) Assessed according to the Eastern Cooperative Oncology Group (ECOG),
d) Chi-square test,
e) According to the International Federation of Gynecology and Obstetrics (2008),
f) Assessed by Response Evaluation Criteria in Solid Tumors (v1.1).
Toxicity | Cisplatin (n=126) | Gemcitabine (n=63) | p-valueb) | ||
---|---|---|---|---|---|
|
|
||||
G1–2 | G3–4 | G1–2 | G3–4 | ||
Neutropenia | 57 (45.2) | 7 (5.5) | 24 (38.0) | 4 (6.3) | 0.646 |
|
|||||
Leukopenia | 98 (77.7) | 13 (10.3) | 29 (46.0) | 3 (4.8) | < 0.001 |
|
|||||
Lymphopenia | 70 (55.5) | 35 (27.8) | 9 (14.3) | 1 (1.6) | < 0.001 |
|
|||||
Anemia | 22 (17.4) | - | 11 (17.4) | 2 (3.2) | 0.132 |
|
|||||
Thrombocytopenia | 7 (5.5) | - | 4 (6.3) | - | 0.530 |
|
|||||
Nausea | 110 (87.3) | 7 (5.6) | 59 (93.6) | - | 0.155 |
|
|||||
Vomit | 69 (54.7) | 4 (3.2) | 49 (77.7) | - | 0.003 |
|
|||||
Constipation | 14 (11.1) | - | 18 (28.5) | - | 0.003 |
|
|||||
Diarrhea | 63 (50.0) | 5 (4.0) | 44 (69.8) | 8 (12.7) | < 0.001 |
|
|||||
Pruritus | 3 (2.4) | - | 3 (4.7) | - | 0.318 |
|
|||||
Fever | 3 (2.4) | - | 11 (17.5) | - | < 0.001 |
|
|||||
Neuropathy | 8 (6.3) | - | 1 (1.6) | - | 0.047 |
|
|||||
Cephalea | 9 (7.1) | - | 5 (7.9) | - | 0.522 |
|
|||||
Anorexia | 3 (2.4) | - | 3 (4.7) | 1 (1.6) | 0.244 |
|
|||||
Fatigue | 71 (56.3) | - | 55 (87.3) | 1 (1.6) | < 0.001 |
|
|||||
Edema | 2 (1.6) | - | 5 (7.9) | - | 0.042 |
|
|||||
Abdominal pain | 37 (29.3) | - | 27 (42.8) | - | 0.065 |
|
|||||
Non-infectious cystitis | 23 (18.2) | 1 (0.8) | 27 (42.8) | - | 0.001 |
|
|||||
Proctitis | 14 (11.1) | 10 (7.9) | 4 (6.3) | 3 (4.8) | 0.381 |
|
|||||
Dermal toxicity | 14 (11.1) | 1 (0.8) | 3 (4.7) | 1 (1.6) | 0.516 |
Treatment group | Pre-treatment | Post-treatment (1 year) | ΔGFR | p-valueb) |
---|---|---|---|---|
Cisplatin | 94.5 | 90.9 | −3.6 | 0.002 |
Gemcitabine | 93.2 | 95.1 | +1.9 | 0.667 |
p=0.025c) |
Clinical characteristics of locally advanced cervical cancer patients
Characteristic | Total patients (n=189) | Cisplatin (n=126) | Gemcitabine (n=63) | p-value |
---|---|---|---|---|
Age (yr) |
56.3±11.5 | 55.4±10.9 | 57.9±12.5 | 0.668 |
Performance status | ||||
ECOG 0 | 77 (40.7) | 47 (37.3) | 30 (47.6) | 0.348 |
ECOG 1 | 107 (56.6) | 76 (60.3) | 31 (49.2) | |
ECOG 2 | 5 (2.6) | 3 (2.4) | 2 (3.2) | |
Clinical stage | ||||
IB2 | 12 (6.3) | 8 (6.3) | 4 (6.3) | 0.975 |
IIA | 6 (3.2) | 4 (3.2) | 2 (3.2) | |
IIB | 108 (57.1) | 72 (57.1) | 36 (57.1) | |
IIIA | 1 (0.5) | 1 (0.8) | 0 | |
IIIB | 59 (31.2) | 39 (31.0) | 20 (31.7) | |
IVB | 3 (1.6) | 2 (1.6) | 1 (1.6) | |
Hemoglobin (g/dL) | 12.8±2.04 | 12.9±2.02 | 12.7±2.05 | 0.574 |
Histology | ||||
Squamous cell carcinoma | 157 (83.1) | 102 (81.0) | 55 (87.3) | 0.536 |
Adenocarcinoma | 23 (12.2) | 17 (13.5) | 6 (9.5) | |
Adenosquamous carcinoma | 9 (4.8) | 7 (5.6) | 2 (3.2) | |
Comorbidities | ||||
Number | 1.24±0.48 | 1.23±0.50 | 1.26±0.44 | 0.051 |
Comorbidities=1 | 148 (78.3) | 102 (80.9) | 46 (73.9) | 0.212 |
Comorbidities ≥ 2 | 41 (21.6) | 24 (19.0) | 17 (26.9) | |
T2DM | 89 (46.8) | 57 (45.2) | 32 (50.8) | < 0.001 |
SAH | 112 (58.9) | 81 (64.3) | 31 (49.2) | |
Acute kidney injury | 19 (10.0) | 14 (11.1) | 5 (7.9) | |
Other | 15 (7.9) | 3 (2.4) | 12 (19.0) | |
Response rates | ||||
Complete response | 165 (87.3) | 109 (86.5) | 56 (88.9) | 0.094 |
Partial response | 9 (4.7) | 4 (3.2) | 5 (7.9) | |
Disease progression | 15 (7.9) | 13 (10.3) | 2 (3.2) | |
Pattern of failure | ||||
Local | 12 (6.3) | 7 (5.5) | 5 (7.9) | 0.917 |
Locoregional | 9 (4.7) | 6 (4.7) | 3 (4.7) | |
Distant metastasis | 35 (18.5) | 22 (17.4) | 13 (20.6) | |
Locoregional+distant metastasis | 16 (8.4) | 14 (11.1) | 2 (3.1) | |
Persistent disease | 13 (6.8) | 10 (7.9) | 3 (4.7) |
Values are presented as mean±SD or number (%). SAH, systemic arterial hypertension; SD, standard deviation; T2DM, type 2 diabetes mellitus.
a)Kolmogorov-Smirnov test (normal distribution is assumed),
b)Student T test for independent samples,
c)Assessed according to the Eastern Cooperative Oncology Group (ECOG),
d)Chi-square test,
e)According to the International Federation of Gynecology and Obstetrics (2008),
f)Assessed by Response Evaluation Criteria in Solid Tumors (v1.1).
Acute toxicity according to treatment groups
Toxicity | Cisplatin (n=126) | Gemcitabine (n=63) | p-value | ||
---|---|---|---|---|---|
|
| ||||
G1–2 | G3–4 | G1–2 | G3–4 | ||
Neutropenia | 57 (45.2) | 7 (5.5) | 24 (38.0) | 4 (6.3) | 0.646 |
| |||||
Leukopenia | 98 (77.7) | 13 (10.3) | 29 (46.0) | 3 (4.8) | < 0.001 |
| |||||
Lymphopenia | 70 (55.5) | 35 (27.8) | 9 (14.3) | 1 (1.6) | < 0.001 |
| |||||
Anemia | 22 (17.4) | - | 11 (17.4) | 2 (3.2) | 0.132 |
| |||||
Thrombocytopenia | 7 (5.5) | - | 4 (6.3) | - | 0.530 |
| |||||
Nausea | 110 (87.3) | 7 (5.6) | 59 (93.6) | - | 0.155 |
| |||||
Vomit | 69 (54.7) | 4 (3.2) | 49 (77.7) | - | 0.003 |
| |||||
Constipation | 14 (11.1) | - | 18 (28.5) | - | 0.003 |
| |||||
Diarrhea | 63 (50.0) | 5 (4.0) | 44 (69.8) | 8 (12.7) | < 0.001 |
| |||||
Pruritus | 3 (2.4) | - | 3 (4.7) | - | 0.318 |
| |||||
Fever | 3 (2.4) | - | 11 (17.5) | - | < 0.001 |
| |||||
Neuropathy | 8 (6.3) | - | 1 (1.6) | - | 0.047 |
| |||||
Cephalea | 9 (7.1) | - | 5 (7.9) | - | 0.522 |
| |||||
Anorexia | 3 (2.4) | - | 3 (4.7) | 1 (1.6) | 0.244 |
| |||||
Fatigue | 71 (56.3) | - | 55 (87.3) | 1 (1.6) | < 0.001 |
| |||||
Edema | 2 (1.6) | - | 5 (7.9) | - | 0.042 |
| |||||
Abdominal pain | 37 (29.3) | - | 27 (42.8) | - | 0.065 |
| |||||
Non-infectious cystitis | 23 (18.2) | 1 (0.8) | 27 (42.8) | - | 0.001 |
| |||||
Proctitis | 14 (11.1) | 10 (7.9) | 4 (6.3) | 3 (4.8) | 0.381 |
| |||||
Dermal toxicity | 14 (11.1) | 1 (0.8) | 3 (4.7) | 1 (1.6) | 0.516 |
Values are presented as number (%).
a)Assessed by Common Terminology Criteria for Adverse Events (v.4.03),
b)Chi-square test.
Change in glomerular filtration rate
Treatment group | Pre-treatment | Post-treatment (1 year) | ΔGFR | p-value |
---|---|---|---|---|
Cisplatin | 94.5 | 90.9 | −3.6 | 0.002 |
Gemcitabine | 93.2 | 95.1 | +1.9 | 0.667 |
p=0.025 |
GFR, glomerular filtrationrate.
a)Assessed with the Chronic Kidney Disease Epidemiology Collaboration formula (mL/min/1.73 m2),
b)Wilcoxon test,
c)Difference between groups, Mann-Whitney U test.
Multivariate analysis of variables associated with change in GFR
Variable | OR | 95% CI | p-value |
---|---|---|---|
Type of treatment | |||
Gemcitabine | 1 (reference) | ||
Cisplatin | 2.425 | 1.211–4.858 | 0.012 |
No. of comorbidities | |||
1 | 1 (reference) | ||
≥ 2 | 0.659 | 0.301–1.444 | 0.298 |
Clinical stage | |||
IB2, IIA, IIB | 1 (reference) | ||
IIIA, IIIB, IVB | 1.446 | 0.718–2.912 | 0.301 |
Age | 0.975 | 0.946–1.004 | 0.095 |
CI, confidence interval; GFR, glomerular filtrationrate; OR, odds ratio.
a)Assessed with the Chronic Kidney Disease Epidemiology Collaboration formula (mL/min/1.73 m2).
Values are presented as mean±SD or number (%). SAH, systemic arterial hypertension; SD, standard deviation; T2DM, type 2 diabetes mellitus. Kolmogorov-Smirnov test (normal distribution is assumed), Student T test for independent samples, Assessed according to the Eastern Cooperative Oncology Group (ECOG), Chi-square test, According to the International Federation of Gynecology and Obstetrics (2008), Assessed by Response Evaluation Criteria in Solid Tumors (v1.1).
Values are presented as number (%). Assessed by Common Terminology Criteria for Adverse Events (v.4.03), Chi-square test.
GFR, glomerular filtrationrate. Assessed with the Chronic Kidney Disease Epidemiology Collaboration formula (mL/min/1.73 m2), Wilcoxon test, Difference between groups, Mann-Whitney U test.
CI, confidence interval; GFR, glomerular filtrationrate; OR, odds ratio. Assessed with the Chronic Kidney Disease Epidemiology Collaboration formula (mL/min/1.73 m2).