Preoperative prediction of suboptimal resection in advanced ovarian cancer based on clinical and CT parameters

Background Cytoreduction is important as a survival predictor in advanced ovarian cancer. Purpose To determine the prediction of suboptimal resection (SOR) in advanced ovarian cancer based on clinical and computed tomography (CT) parameters. Material and Methods Between 2007 and 2015, 327 consecutive patients with FIGO stage III–IV ovarian cancer and preoperative CT were included. During 2007–2012, patients were assigned to a derivation dataset ( n = 220) and the others were assigned to a validation dataset ( n = 107). Clinical parameters were reviewed and two radiologists assessed the presence or absence of tabulated parameters on CT images. Logistic regression analyses based on area under the receiver-operating characteristic curve (AUROC) were performed to identify variables predicting SOR, and generated simple score using Cox proportional hazards model. Results There was no statistical difference in patients’ characteristics in both datasets, except for residual disease ( P = 0.001). Optimal resection improved from 45.0% (99/220) in the derivation dataset to 64.4% (69/107) in the validation dataset. Logistic regression identified that Eastern Cooperative Oncology Group-performance status (ECOG-PS 2), involvements of peritoneum, diaphragm, bowel mesentery and suprarenal lymph nodes, and pleural effusion were independent variables of SOR. Overall AUROC for score predicting SOR was 0.761 with sensitivity, specificity, and positive and negative predictive values of 70.6%, 73.2%, 68.7%, and 91.9%, respectively. In the derivation dataset, AUROC was 0.792, with sensitivity of 71.4% and specificity of 74.3%, and AUROC of 0.758 with sensitivity of 69.2% and specificity of 72.8% in the validation dataset. Conclusion CT may be a useful preoperative predictor of SOR in advanced ovarian cancer.

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When Ovarian Cancer Is Not: Characterizing Nonovarian Cancer Pathology in a Laparoscopy-Based Triage System

International Journal of Gynecological Cancer ◽

10.1097/igc.0000000000001329 ◽

2018 ◽

Vol 28 (8) ◽

pp. 1485-1490 ◽

Cited By ~ 1

Author(s):

Robert L. Dood ◽

Nicole D. Fleming ◽

Robert L. Coleman ◽

Shannon N. Westin ◽

Olivia D. Lara ◽

...

Keyword(s):

Ovarian Cancer ◽

Group Performance ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Advanced Ovarian Cancer ◽

Percutaneous Biopsy ◽

Histologic Diagnosis ◽

Chemotherapy Administration ◽

Cancer Pathology ◽

Conclusive Diagnosis

ObjectiveEstablishing an accurate histologic diagnosis is essential for determining the appropriate course of therapy for ovarian cancer. This study sought to investigate and describe nonovarian cancer pathologies discovered during the systematic laparoscopic workup of presumed advanced ovarian cancer.MethodsA retrospective cohort of patients with presumed advanced ovarian cancer (based on elevated CA125 and/or imaging) presenting to our center without confirmed pathologic diagnosis were identified and characterized. Patients without ovarian cancer on final pathology were described and compared with those with confirmed epithelial ovarian cancer using standard statistical methods.ResultsNonovarian cancer was found in 26 (7.1%) of 365 cases over 3.5 years of study, and included benign ovarian pathology, and metastatic uterine, breast, and gastrointestinal cancers. Most nonovarian cancer cases could not be diagnosed with percutaneous biopsy, and instead used diagnostic laparoscopy or assessment at the time of laparotomy for diagnosis (58%). No patient received inappropriate treatment. Nonovarian cancer cases were more likely to be nonwhite (P = 0.003), have a better Eastern Cooperative Oncology Group performance status (P < 0.001), and have a lower CA125 value (P < 0.001), and were less likely to have pleural effusions (P = 0.04).ConclusionsA systematic laparoscopic triage approach to advanced-stage ovarian cancer eliminates incorrect neoadjuvant chemotherapy administration and inappropriate laparotomy. This algorithm identified a population of women who are more likely to have nonovarian cancer pathology. Increasing screening efforts should be focused on conclusive diagnosis with the least invasive testing possible.

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Cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide in advanced ovarian cancer: a randomized phase III study of the National Cancer Institute of Canada Clinical Trials Group.

Journal of Clinical Oncology ◽

10.1200/jco.1992.10.5.718 ◽

1992 ◽

Vol 10 (5) ◽

pp. 718-726 ◽

Cited By ~ 136

Author(s):

K Swenerton ◽

J Jeffrey ◽

G Stuart ◽

M Roy ◽

G Krepart ◽

...

Keyword(s):

Ovarian Cancer ◽

Response Rate ◽

Residual Disease ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Advanced Ovarian Cancer ◽

Phase Iii ◽

Treatment Center ◽

Clinical Response Rate ◽

Time To Progression

PURPOSE Given the potential for improved tolerance, a trial was initiated to compare the toxicity and efficacy of a standard regimen of cisplatin-cyclophosphamide (75 mg/m2 and 600 mg/m2, respectively) with an experimental regimen of carboplatin-cyclophosphamide (300 mg/m2 and 600 mg/m2, respectively) in women with postoperative macroscopic residual ovarian cancer. PATIENTS AND METHODS Between 1985 and 1989, 447 (417 eligible) patients were randomized. Treatment arms were well balanced; most patients had stage III (82%), grade 3 (54%) tumors with bulky residual (greater than 2 cm in 59%), and good performance status (Eastern Cooperative Oncology Group [ECOG] 0 or 1, 77%). Response was assessed after six 4-week cycles. RESULTS The treatments were equally deliverable, with 76% of patients completing their allocated regimen. The reported reasons for failure to complete treatment differed; toxicity/refusal predominated on the cisplatin arm, and progressive disease predominated on the carboplatin arm (P = .0092). Cisplatin-treated patients were more likely to develop neuropathy and nephropathy, and carboplatin patients experienced myelosuppression, particularly thrombocytopenia. Efficacy was similar, with no significant differences for the cisplatin and carboplatin arms in clinical response rate (57% v 59% in those with measurable disease), pathologic response rate (52% v 54% in those suitable for relaparotomy), time to progression (median, 56 v 58 weeks), or overall survival (median, 100 weeks v 110 weeks). Time to progression and survival were predicted by residual disease size, performance status, and treatment center (with those treated at centers that accrued more patients doing better). CONCLUSION Neither regimen is optimal in that relapse remains the norm. It may be inappropriate to expect that any single regimen can be an effective therapy for all patients with advanced ovarian cancer. Both cisplatin and carboplatin are likely to have a role in future treatment strategies.

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Multicenter Phase 2 Study of Combined Gemcitabine and Epirubicin as Second-Line Treatment for Patients With Advanced Ovarian Cancer

International Journal of Gynecological Cancer ◽

10.1111/igc.0b013e3181e4a6c1 ◽

2010 ◽

Vol 20 (6) ◽

pp. 953-957 ◽

Cited By ~ 4

Author(s):

Viviana Murgia ◽

Roberto Sorio ◽

Claudia Griso ◽

Orazio Caffo ◽

Carmela Arcuri ◽

...

Keyword(s):

Ovarian Cancer ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Advanced Ovarian Cancer ◽

Hematological Toxicity ◽

Line Treatment ◽

Second Line ◽

Phase 2 ◽

Platinum Resistant ◽

Gynecology And Obstetrics

Objective:The aim of this phase 2 trial was to evaluate the tolerability and efficacy of combined gemcitabine (G) and epirubicin (E) as second-line treatment for patients with advanced ovarian cancer.Methods:Treatment with G 1000 mg/m2 (days 1 and 8) and E 60 mg/m2 (day 1) every 3 weeks for 3 or, in the absence of progression, 6 courses.Results:Fifty patients with advanced ovarian cancer (31 serous, 2 endometrioid, 10 unclassified adenocarcinoma, and 7 other) and a median age of 60 years (range, 38-74 years) were enrolled after giving their informed consent. Performance status according to the Eastern Cooperative Oncology Group was 0 in 29 patients (58%), 1 in 17 patients (34%), and 2 in 4 patients (8%), and the initial stages according to the International Federation of Gynecology and Obstetrics were I to II in 4 patients (8%), III in 31 patients (62%), and IV in 15 patients (30%). They had previously received a median of 1.5 lines of treatment (range, 1-4). The median platinum-free interval was 5 months (range, 0-12 months): 32 patients had relapse within 6 months and 18 patients had relapse after 6 months.The response rate was 42% (2% complete response and 40% partial response), with a median duration of 7.2 months: the corresponding figures were 37.5% and 5.2 months in the platinum-resistant patients and 50% and 8.8 months in the platinum-sensitive patients. The main grade 3 to 4 hematological toxicity was neutropenia (56% of cases). After a median follow-up of 13.5 months, median progression-free survival was 5 months, and median overall survival was 23.5 months.Conclusions:This E + G combination seems to be active and safe in platinum-resistant/refractory patients.

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A randomized trial comparing cisplatin plus cyclophosphamide versus cisplatin, doxorubicin, and cyclophosphamide in advanced ovarian cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1986.4.6.965 ◽

1986 ◽

Vol 4 (6) ◽

pp. 965-971 ◽

Cited By ~ 108

Author(s):

P F Conte ◽

M Bruzzone ◽

S Chiara ◽

M R Sertoli ◽

M G Daga ◽

...

Keyword(s):

Ovarian Cancer ◽

Median Survival ◽

Stable Disease ◽

Residual Disease ◽

Performance Status ◽

Advanced Ovarian Cancer ◽

Progression Free Survival ◽

Complete Response ◽

Free Survival ◽

Second Look

After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) (corrected) or PAC (PC + doxorubicin 45 mg/m2). After six cycles, patients clinically disease-free or with resectable residual disease were submitted to second-look surgery. After restaging, patients in surgical complete response (CR) stopped treatment while those responding partially (PR) received six more courses; patients whose disease progressed were excluded from the study. Among patients with measurable disease, the following clinical response rates were observed: PC = 20% CR, 34.3% PR, 14.3% stable disease, and 31.4% progression; PAC = 40.6% CR, 15.6% PR, 12.5% stable disease, and 31.3% progression. In the 75 patients submitted to second look, the results have been the following: PC = 39.5% CR, 36.8% PR, 7.9% stable disease, and 15.8% progression; PAC = 62.2% CR, 18.9% PR, 10.8% stable disease, and 8.1% progression. The difference in surgical complete response in favor of the PAC regimen is significant (P less than .05). Median survival and progression-free survival were 800 and 400 days, respectively, for PAC arm; median survival and progression-free survival were 680 and 380 days, respectively, for PC. These differences are not significant. Probability of survival was affected by FIGO stage, amount of residual disease, histology, performance status, and response at second look, while no influence was observed according to grade of tumor differentiation and age. Our results demonstrate the usefulness of doxorubicin in terms of surgical CR.

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Consolidation with intraperitoneal cisplatin in first-line therapy of advanced ovarian cancer.

Journal of Clinical Oncology ◽

10.1200/jco.1991.9.5.809 ◽

1991 ◽

Vol 9 (5) ◽

pp. 809-817 ◽

Cited By ~ 9

Author(s):

U Beller ◽

J Speyer ◽

N Colombo ◽

J Sorich ◽

J Wernz ◽

...

Keyword(s):

Ovarian Cancer ◽

Median Survival ◽

Residual Disease ◽

Performance Status ◽

Advanced Ovarian Cancer ◽

Induction Phase ◽

First Line ◽

Control Series ◽

Combined Modality ◽

Initial Surgery

Seventy-five patients with advanced epithelial ovarian cancer were treated with a combined modality regimen of systemic, induction chemotherapy followed by intraperitoneal therapy (IPT). All patients underwent initial surgery for staging and/or cytoreduction followed by cisplatin 20 mg/m2 intravenously (IV) for 5 days and cyclophosphamide 600 mg/m2 on day 4 every 3 to 4 weeks for two to four cycles. Patients were then evaluated for IPT and, if eligible, had an intraperitoneal (IP) catheter placed. IPT consisted of cisplatin 60 mg/m2 in 2 L on day 1 and IV cyclophosphamide 600 mg/m2 on day 2 every 3 weeks for three to six cycles. Patients who demonstrated a clinical complete response (CCR) were then referred for second-look laparotomy (SLL). Of 71 patients who completed the induction phase, 53 (75%) were eligible for IPT, and 49 patients entered the therapy phase. Toxicity of the combined modality approach was acceptable and did not differ from our previous experience using the same drugs systemically. Thirty-two of the 49 patients who completed IPT achieved a CCR, which was confirmed by SLL in 20 patients. Twenty recurrences were documented in the 32 CCR patients, 13 occurred in patients after SLL. Projected median survival of all patients is 38 months. Median survival correlated with amount of residual disease following initial surgery (23 months for bulky v 45 months for minimal residual; P less than .001) and with performance status ([PS]; 24 months for PS 2, 3 v greater than 46 months for PS O; P less than .001). Patients who presented with bulky tumors were less likely to reach the consolidation IPT phase. Incorporation of IP cisplatin into the first-line regimen for treatment of ovarian cancer does not appear to have major impact on the survival of all treated patients when compared with our historical control series. Combined IV and IPT cisplatin and cyclophosphamide is feasible with acceptable toxicity. Its impact on response and survival may be limited to only "good-prognosis" patients.

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CyBorD-DARA is potent initial induction for MM and enhances ADCP: initial results of the 16-BCNI-001/CTRIAL-IE 16-02 study

Blood Advances ◽

10.1182/bloodadvances.2019000010 ◽

2019 ◽

Vol 3 (12) ◽

pp. 1815-1825 ◽

Cited By ~ 4

Author(s):

M. O’Dwyer ◽

R. Henderson ◽

S. D. Naicker ◽

M. R. Cahill ◽

P. Murphy ◽

...

Keyword(s):

Partial Response ◽

Group Performance ◽

Residual Disease ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Staging System ◽

Complete Response ◽

Weekly Schedule ◽

Intention To Treat ◽

Good Partial Response

Abstract Daratumumab (DARA) has shown impressive activity in combination with other agents for the treatment of multiple myeloma (MM). We conducted a phase 1b study to assess the safety and preliminary efficacy, as well as potential mechanisms of action, of DARA (16 mg/kg) in combination with a weekly schedule of subcutaneous bortezomib (1.3-1.5 mg/m2), cyclophosphamide (150-300 mg/m2), and dexamethasone (40 mg) (CyBorD DARA) as initial induction before autologous stem cell transplantation (ASCT). Eligible patients were ≤70 years of age with untreated MM requiring treatment and who lacked significant comorbidities. A total of 18 patients were enrolled. Their median age was 56 years (range, 32-66 years), and all patients had Eastern Cooperative Oncology Group performance status ≤1. The International Staging System stages were I, II, and III in 78%, 17%, and 6% of patients, respectively; 28% of patients had high-risk genetic features. There was no dose-limiting toxicity, and the incidence of grade 3 or 4 infection or neutropenia was <10%. On an intention-to-treat basis, 94% achieved ≥very good partial response with ≥complete response in 44% of patients. Among 14 of 15 patients who underwent ASCT and were evaluable for response, all 14 achieved at least very good partial response, with 8 (57%) of 14 achieving complete response. After ASCT, 10 (83%) of 12 patients in whom minimal residual disease analysis was possible were negative at a sensitivity of 10−5 (56% on intention-to-treat/whole study population) according to next-generation sequencing. Flow cytometry analysis of patient samples indicated CyBorD DARA induced activation of macrophage-mediated antibody-dependent cellular phagocytosis. This trial was registered at www.clinicaltrials.gov as #NCT02955810.

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Prognostic Nomogram for Patients With Unresectable Pancreatic Cancer Treated With Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX: Real-world Results From a Multicenter Retrospective Study (NAPOLEON study).

10.21203/rs.3.rs-132462/v1 ◽

2020 ◽

Author(s):

Taro Shibuki ◽

Toshihiko Mizuta ◽

Mototsugu Shimokawa ◽

Futa Koga ◽

Yujiro Ueda ◽

...

Keyword(s):

Pancreatic Cancer ◽

Risk Stratification ◽

Proportional Hazards Model ◽

Group Performance ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Calibration Plot ◽

Unresectable Pancreatic Cancer

Abstract Background No reliable nomogram has been developed until date for predicting the survival in patients with unresectable pancreatic cancer undergoing treatment with gemcitabine plus nab-paclitaxel (GnP) or FOLFIRINOX (FFX).Methods This analysis was conducted using clinical data of patients with unresectable pancreatic cancer undergoing GnP or FFX treatment obtained from a multicenter study (NAPOLEON study). A Cox proportional hazards model was used to identify the independent prognostic factors. A nomogram to predict 6-, 12-, and 18-month survival probabilities was generated, validated by using the concordance index (C-index), and calibrated by the bootstrapping method. And then, we attempted risk stratification for survival by classifying the patients according to the sum of the scores on the nomogram (total nomogram points; TNP).Results A total of 318 patients were enrolled. A prognostic nomogram was generated using data on the Eastern Cooperative Oncology Group performance status, liver metastasis, serum LDH, serum CRP, and serum CA19-9. The C-indexes of the nomogram were 0.77, 0.72 and 0.70 for 6-, 12-, and 18-month survival, respectively. The calibration plot showed optimal agreement at all points. Risk stratification based on tertiles of the TNP yielded clear separations of the survival curves. The median survival times in the low-, moderate-, and high-risk groups were 15.8, 12.8 and 7.8 months (P<0.05), respectively.Conclusions: Our nomogram is a convenient and inexpensive tool to accurately predict survival in patients with unresectable pancreatic cancer undergoing treatment with GnP or FFX, and will help clinicians in selecting appropriate therapeutic strategies for individualized management.

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Anlotinib in combination with TQB2450 in patients with recurrent ovarian cancer (ACTION): A multicenter, single-arm, open-label, phase Ib trial.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.5557 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 5557-5557

Author(s):

Chunyan Lan ◽

Jing Zhao ◽

Fan Yang ◽

Rong Li ◽

Yu Huang ◽

...

Keyword(s):

Ovarian Cancer ◽

Group Performance ◽

Gynecologic Cancer ◽

Objective Response ◽

Eastern Cooperative Oncology Group ◽

Advanced Ovarian Cancer ◽

Open Label ◽

Phase Ib ◽

Platinum Based Chemotherapy ◽

Duration Of Response

5557 Background: Combination of antiangiogenic therapy and immune checkpoint inhibitor therapy is reported as an effective antitumor strategy. TQB2450 is a humanized IgG1 monoclonal antibody against programmed death-ligand 1 (PD-L1). We aimed to assess the activity and safety of TQB2450 plus the antiangiogenic multi-target tyrosine kinase inhibitor anlotinib in patients with recurrent advanced ovarian cancer. Methods: The study with ClinicalTrials.gov identifier NCT04236362 is an open-label, multicohort, and multicenter phase Ib trial evaluating the efficacy and safety of anlotinib combined with TQB2450 in patients with advanced gynecologic cancer. The present study (ACTION study) reports the ovarian cancer cohort. We enrolled patients aged 18–70 years with platinum-resistant or platinum-refractory epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Eligible patients received anlotinib 12 mg per day orally on days 1 to 14 and TQB2450 1200 mg intravenously on day 1, every three weeks. Treatment continued until disease progression, unacceptable toxicity, and withdrawal of consent. The primary endpoint was objective response rate (ORR) assessed by investigators according to RECIST version 1.1. Secondary endpoints included progression-free survival (PFS), duration of response (DOR), overall survival (OS) and safety. Results: Between 21 Feb 2020 and 15 Jan 2021, 33 patients with a median age of 55 years (range, 26-71) were enrolled and received study treatment. Patients had received at least once platinum-based chemotherapy, and the median number of previous chemotherapy lines was 3 (range, 1–6). 30.3% patients had bevacizumab therapy before enrollment. At data cutoff (15 Jan 2021), the median follow-up was 5.1 months (range, 0.1–10.8). In the 25 efficacy-evaluable patients, 13 of them achieved partial response, yielding the ORR of 52.0% (95% CI, 30.4%–71.6%). The median PFS was 6.7 months (95% CI, 4.5 months to not reached). The median duration of response and the median OS were not reached. The treatment-related grade 3 or 4 adverse events (AEs) occurred in 54.5% patients, and the most common ones were palmar-plantar erythrodysesthesia syndrome (21.2%) and hypertension (18.2%). The most potential immune-related AEs included grade 1 to 2 hypothyroidism (24.2%) and fatigue (9.1%). No treatment-related death was recorded. Conclusions: Anlotinib plus TQB2450 showed encouraging antitumor activity and tolerable toxicity in patients with recurrent advanced ovarian cancer. Clinical trial information: NCT04236362.

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Depression in Family Caregivers of Cancer Patients: The Feeling of Burden As a Predictor of Depression

Journal of Clinical Oncology ◽

10.1200/jco.2007.15.3957 ◽

2008 ◽

Vol 26 (36) ◽

pp. 5890-5895 ◽

Cited By ~ 157

Author(s):

Young Sun Rhee ◽

Young Ho Yun ◽

Sohee Park ◽

Dong Ok Shin ◽

Kwang Mi Lee ◽

...

Keyword(s):

Logistic Regression ◽

Cancer Patients ◽

Family Caregivers ◽

Group Performance ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Cancer Center ◽

Family Impact ◽

Caregiver Depression ◽

Quality Of Life Index

Purpose The purpose of this study was to explore the prevalence of and to identify the predictors of depression in family caregivers of cancer patients. Patients and Methods We enrolled 310 caregivers of cancer patients from the National Cancer Center, Korea, on this study and obtained demographic information for both patients and caregivers. To assess caregiver depression and its predictors, we used the Beck Depression Inventory (BDI), the Caregiver Quality of Life Index–Cancer, and the Family Impact Questionnaire. We used logistic regression analysis to identify independent predictors of caregiver depression. Results The majority (67%) of caregivers had high depression scores (BDI > 13), and 35% had very high depression scores (BDI > 21). In a multiple logistic regression model, caregivers who were women, the spouse of the patient, in poor health, feeling burdened, adapting poorly, unable to function normally, or caring for a patient with poor Eastern Cooperative Oncology Group performance status were more likely to experience depression (P < .01 for all values). Conclusion Depression was highly prevalent among cancer patient family caregivers, and care burden was its best predictor. Interventions aimed at reducing the psychiatric effects of cancer should focus not only on the patient but also on the caregiver.

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Prognostic nomogram for patients with unresectable pancreatic cancer treated with gemcitabine plus nab–paclitaxel or FOLFIRINOX: A post–hoc analysis of a multicenter retrospective study in Japan (NAPOLEON study)

BMC Cancer ◽

10.1186/s12885-021-09139-y ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

Taro Shibuki ◽

Toshihiko Mizuta ◽

Mototsugu Shimokawa ◽

Futa Koga ◽

Yujiro Ueda ◽

...

Keyword(s):

Pancreatic Cancer ◽

Risk Stratification ◽

Proportional Hazards Model ◽

Group Performance ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Japanese Patients ◽

Cox Proportional Hazards Model ◽

Calibration Plot ◽

Unresectable Pancreatic Cancer

Abstract Background No reliable nomogram has been developed until date for predicting the survival in patients with unresectable pancreatic cancer undergoing treatment with gemcitabine plus nab–paclitaxel (GnP) or FOLFIRINOX. Methods This analysis was conducted using clinical data of Japanese patients with unresectable pancreatic cancer undergoing GnP or FOLFIRINOX treatment obtained from a multicenter study (NAPOLEON study). A Cox proportional hazards model was used to identify the independent prognostic factors. A nomogram to predict 6–, 12–, and 18–month survival probabilities was generated, validated by using the concordance index (C–index), and calibrated by the bootstrapping method. And then, we attempted risk stratification for survival by classifying the patients according to the sum of the scores on the nomogram (total nomogram points). Results A total of 318 patients were enrolled. A prognostic nomogram was generated using data on the Eastern Cooperative Oncology Group performance status, liver metastasis, serum LDH, serum CRP, and serum CA19–9. The C–indexes of the nomogram were 0.77, 0.72 and 0.70 for 6–, 12–, and 18–month survival, respectively. The calibration plot showed optimal agreement at all points. Risk stratification based on tertiles of the total nomogram points yielded clear separations of the survival curves. The median survival times in the low–, moderate–, and high–risk groups were 15.8, 12.8 and 7.8 months (P<0.05), respectively. Conclusions Our nomogram might be a convenient and inexpensive tool to accurately predict survival in Japanese patients with unresectable pancreatic cancer undergoing treatment with GnP or FOLFIRINOX, and will help clinicians in selecting appropriate therapeutic strategies for individualized management.

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