Cioffi 2018.
Study characteristics | ||
Methods | Single‐centre retrospective study | |
Participants | N = 102 participants who received a diagnosis of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or IV EOC between 2000 and 2016, received neoadjuvant chemotherapy, and presented at least one of the following:
Participants were stratified according to their age: ≥ 70 vs < 70 Age (mean): 74.5 (≥ 70 years) and 58.3 (< 70 years) FIGO: III ‐ 64 (62.7%); IV ‐ 38 (37.3%) Histology: serous ‐ 58 (56.9%); undifferentiated ‐ 1 (1%); endometrioid ‐ 14 (13.7%); sero‐endometrioid ‐ 21 (20.6%); clear cell ‐ 3 (2.9%); unknown ‐ 5 (4.9%) Ascites (≥ 500 mL): 76 (74.5%) Tumour grade: G1 ‐ 0; G2 ‐ 8 (7.8%); G3 ‐ 80 (78.4%); unknown ‐ 14 (13.7%) CA‐125 at diagnosis (median): 2934.1 (≥ 70 years) and 1462 (< 70 years) |
|
Residual disease details | All women received platinum‐based regimens, according to standard first‐line protocols. After receiving 3 cycles of NACT, women were evaluated by computed tomography (CT) scan or positron emission tomography (PET)–CT scan; radiologic response was assessed according to RECIST 1.1. Women showing complete response (CR) or partial response (PR) to chemotherapy, and considered respectable by a gynaecologic oncologist team, underwent IDS. Women with either stable disease (SD) or progressive disease (PD) after 3 NACT cycles were re‐evaluated after 3 further chemotherapy cycles. Women showing CR, PR or SD after 6 chemotherapy cycles underwent debulking surgery. Carboplatin AUC5 and paclitaxel 175 mg/m2 every 3 weeks: 58 (56.9%) Carboplatin AUC5, paclitaxel 175 mg/m2 and bevacizumab (15 mg/kg) on day 1 for 6 x 3‐weekly courses followed by bevacizumab single‐agent maintenance for 22 cycles or until toxicity or progression: 11 (10.8%) Carboplatin AUC5 every 3 weeks: 25 (24.5%) Carboplatin AUC2 and paclitaxel 60 mg/m2 weekly: 5 (4.9%) Carboplatin AUC2 weekly: 3 (2.9%) Response to NAC (RECIST):
Optimal cytoreduction defined as residual disease no greater than 1 cm (RD ≤ 1 cm) (n = 57; 67.1%)
|
|
Outcomes | Overall survival defined as interval from the date of initial diagnosis to the date of death or last follow‐up Median overall survival: 25 months Multivariate Cox PH model for overall survival adjusted for age, number of chemotherapy courses, debulking surgery, ASA score, hypoalbuminaemia (defined as albuminaemia < 32 g/L), FIGO stage, presence of ascites, high tumour dissemination and Charlson comorbidity score:
Progression‐free survival defined as interval from the date of initial diagnosis to the date of first recurrence, death or last follow‐up. Median progression‐free survival: 11 months Multivariate Cox PH model for PFS adjusted for age, number of chemotherapy courses, debulking surgery, ASA score, hypoalbuminaemia (defined as albuminaemia < 32 g/L), FIGO stage, presence of ascites ≥ 500 mL, high tumour dissemination and Charlson comorbidity score:
|
|
Risk of bias (QUIPS) | 1. Study participation (a‐f): low risk Adequate number of participants and description of target population. Baseline characteristics, eligibility criteria, sampling frame and period/place study took place presented clearly. 2. Study attrition (a‐e): unclear risk Unclear if patients with incomplete follow‐up were excluded before arriving at the stated sample size Insufficient information to permit judgement. 3. Prognostic factor measurement (a‐f): low risk Valid and reliable measurement of RD Outcome level assessment: Outcome: overall survival 4. Outcome measurement (a‐c): low risk Valid and reliable measurement of outcome. Overall survival defined as interval from the date of initial diagnosis to the date of death or last follow‐up. 5. Adjustment for other prognostic factors (a‐g): low risk HR for OS was adjusted for residual disease, age, number of neoadjuvant chemotherapy courses, debulking surgery, ASA score, hypoalbuminaemia (defined as albuminaemia < 32 g/L), FIGO stage, presence of ascites ≥ 500 mL, high tumour dissemination and Charlson comorbidity score 6. Statistical analysis and reporting (a‐d): unclear risk No conceptual framework; although appears all variables were used in the multivariate models Outcome: progression‐free survival 4. Outcome measurement (a‐c): low risk Valid and reliable measurement of outcome. Progression‐free survival defined as interval from the date of initial diagnosis to the date of first recurrence, death, or last follow‐up. 5. Adjustment for other prognostic factors (a‐g): low risk HR for PFS was adjusted for residual disease, age, number of neoadjuvant chemotherapy courses, debulking surgery, ASA score, hypoalbuminaemia (defined as albuminaemia < 32 g/L), FIGO stage, presence of ascites ≥ 500 mL, high tumour dissemination and Charlson comorbidity score. 6. Statistical analysis and reporting (a‐d): unclear risk No conceptual framework; although appears all variables were used in the multivariate models |
|
Notes | ASA score: 1: 5 (4.9%); 2: 36 (35.3%); 3: 51 (50%); 4: 7 (6.9%) BMI (mean): 24.4 (≥ 70 years) and 25.5 (< 70 years) Charlson comorbidity score ≥1: 27 (26.5%) Procedures before NAC: diagnostic laparoscopy: 78 (27.7%); clinical exam/imaging: 196 (69.5%); unknown: 8 (2.8%) |