Dose-Dense Sequential Chemotherapy With Epirubicin and Paclitaxel Versus the Combination, as First-Line Chemotherapy, in Advanced Breast Cancer: A Randomized Study Conducted by the Hellenic Cooperative Oncology Group

PURPOSE: To compare the efficacy of two different schedules of epirubicin and paclitaxel, as first-line chemotherapy, in patients with advanced breast cancer (ABC). PATIENTS AND METHODS: From October 1997 until May 1999, 183 eligible patients with ABC entered the study. Chemotherapy in group A (93 patients) consisted of four cycles of epirubicin at a dose of 110 mg/m2 followed by four cycles of paclitaxel at a dose of 225 mg/m2 in a 3-hour infusion. All cycles were repeated every 2 weeks with granulocyte colony-stimulating factor support. The therapeutic regimen in group B (90 patients) consisted of epirubicin (80 mg/m2) immediately followed by paclitaxel (175 mg/m2 in a 3-hour infusion) every 3 weeks for six cycles. RESULTS: In total, 79 patients (85%) in group A and 72 patients (80%) in group B completed treatment. The median relative dose-intensity of epirubicin was 0.96 in both groups, and that of paclitaxel was 0.96 and 0.97 in groups A and B, respectively. The complete response rate was higher in group A (21.5% v 9% P = .02). Nevertheless, there was no significant difference in the overall response rate between the two groups (55% v 42%, P = .10). Severe neutropenia was more frequently observed with concurrent treatment. After a median follow-up of 16.5 months, median time to progression was 10 months in group A and 8.5 months in group B (P = .27), and median survival was 21.5 and 20 months, respectively (P = .17). CONCLUSION: The present study failed to demonstrate a significant difference in overall response rate between dose-dense sequential administration of epirubicin and paclitaxel compared with the combination of the two drugs given on the same day, even though the sequential treatment resulted in a significantly higher complete response rate.

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Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

10.21203/rs.3.rs-55589/v3 ◽

2020 ◽

Author(s):

Jian Sun ◽

Wenjie Wang ◽

Jing Ding ◽

Yusheng Cheng ◽

Yunfeng Zhou ◽

...

Keyword(s):

Side Effects ◽

Response Rate ◽

Complete Response Rate ◽

Complete Response ◽

Single Side ◽

Female Genital Tuberculosis ◽

Group A ◽

Intent To Treat ◽

Group B ◽

Female Genital

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT.Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9-12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 18-35 yr) and group B (aged 36-81 yr). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-month duration.Conclusions Younger females with FGTB had a greater risk of systemic infection of tuberculosis compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for reducing side effects and poor compliance in the duration of treatment.

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Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

10.21203/rs.3.rs-55589/v1 ◽

2020 ◽

Author(s):

Jianghua Yang ◽

Jian Sun ◽

Wenjie Wang ◽

Jing Ding ◽

Yusheng Cheng ◽

...

Keyword(s):

Side Effects ◽

Response Rate ◽

Complete Response Rate ◽

Complete Response ◽

Single Side ◽

Female Genital Tuberculosis ◽

Group A ◽

Intent To Treat ◽

Group B ◽

Female Genital

Abstract Background Duration of antituberculosis therapy (ATT) for managing female genital tuberculosis (FGTB) is controversial with the intermittent regimen no more advocated. We therefore conducted a prospective, real-world research to compare 6 months and 9 months of ATT. Methods Between 2012 and 2018, 109 drug-susceptible patients newly diagnosed with FGTB and/or tuberculous peritonitis (genital, 13; peritoneal, 34; mixed, 62) received naïve treatment for 9–12 months and further 18-month follow-up. Data on disease features at baseline and long-term outcome (intent-to-treat) were compared between group A (aged 15–35 years) and group B (aged ≥ 36 years). Efficacy and side effects of treatment were compared within each group 6 months and 9 months from ATT initiation (per-protocol), respectively. Results In contrast to group B at baseline, group A had more clinical evidence predicting active tuberculosis (P < 0.05), severer performance of genital lesions and pelvic adhensions (P < 0.05), more signs of active pulmonary tuberculosis (P < 0.01), and less performance of only TBP (P < 0.01). Intent-to-treat analysis showed higher incidence of overall single side effects and poor compliance in group B (P < 0.05), and similar recurrence rate between 2 groups. Per-protocol analysis showed increased complete response rate (P < 0.01) and similar incidence of side effects (P > 0.05) in group A, similar complete response rate (P > 0.05) and increased incidence of overall single side effects (P < 0.05) in group B at 9-mo duration. Conclusions Younger females with FGTB had a greater risk of systemic infection of TB compared to older ones. Nine-month ATT using daily therapy proved to be beneficial for younger patients at reproductive age. Six-month option was suitable for older patients for improving the side effects and poor compliance in the duration of treatment.

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A night on call or an overnight shift does not reduce residents’ empathy: a randomized crossover multicenter survey

BMC Medical Education ◽

10.1186/s12909-019-1822-5 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Michiko Mizobe ◽

Hitomi Kataoka ◽

Hiroshi Yamagami ◽

Chikao Ito ◽

Yasuaki Koyama ◽

...

Keyword(s):

Overall Response Rate ◽

Response Rate ◽

Shift Group ◽

Resident Physicians ◽

Academic Hospitals ◽

Multicenter Survey ◽

Significant Difference ◽

Group A ◽

Group B ◽

Physician Empathy

Abstract Background Studies have shown that sleep deprivation may reduce empathy among medical students. Yet, little is known about the empathy after a night on call or an overnight shift among resident physicians. Hence, we aimed to examine whether a night on call or an overnight shift reduces the physicians’ empathy. Methods We conducted a multicenter randomized crossover survey using the Jefferson Scale of Physician Empathy (JSE). A total of 260 physicians who worked at academic hospitals and community hospitals in Japan in 2016 were recruited and randomized into two groups. Group A first completed the JSE prior to a night on call or an overnight shift; then, 8 weeks later, Group A completed the JSE after a night on call or an overnight shift. Group B first completed the JSE after a night on call or an overnight shift; then, 8 weeks later, Group B completed the JSE prior to a night on call or an overnight shift. Statistical analyses were performed to compare the JSE scores of pre- and post-night on call or overnight shifts. Results A total of 117 Group A physicians and 112 Group B physicians returned a completed JSE. The overall response rate was 88.08%. There was no significant difference in the JSE scores between pre- and post-night on call or overnight shift. (Group A before night vs Group B after night, p = 0.40, Group A after night vs Group B before night, p = 0.68). Conclusion As per our results, a night on call or an overnight shift did not reduce the Japanese physicians’ empathy. To the best of our knowledge, this is the first study on physicians’ empathy after a night on call or an overnight shift.

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Impact of Cumulative Dose of Carfilzomib in Combination with Lenalidomide and Desamethasone in Relapsed Refractory Myeloma Patients: A Retrospective Real Life Survey of the Sicilian Myeloma Network

Blood ◽

10.1182/blood-2018-99-116452 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 5636-5636

Author(s):

Concetta Conticello ◽

Enrica Antonia Martino ◽

Vittorio Del Fabro ◽

Giuseppe Sapienza ◽

Valeria Calafiore ◽

...

Keyword(s):

Adverse Events ◽

Cumulative Dose ◽

Overall Response Rate ◽

Response Rate ◽

Real Life ◽

Previous Treatment ◽

Complete Response ◽

Overall Response ◽

Group A ◽

Group B

Abstract Background: Triplet-based lenalidomide plus dexamethasone (Rd) combinations have become the new standard of care for early relapse and refractory multiple myeloma (RRMM). Carfilzomib is a novel selective proteasome inhibitor (PI) with high efficacy in RRMM. The ASPIRE phase 3 trial showed the superiority of carfilzomib-based triplet (KRd compared to Rd), leading to approval of K for RRMM. However, little is known about safety and efficacy of KRd outside a clinical trial context. Experimental design and aims: In 11 Sicilian Centers belonging to the Sicilian Myeloma Network, from November 2016, when KRd regimen was approved in Italy, to June 2018, 103 consecutive RRMM patients (previous lines 1-10) have received KRd regimen, according to ASPIRE schedule. Lenalidomide dosage was reduced in patients with a low count of platelet and/or renal failure according to manufacturer guidelines. Since previous studies have demonstrated that increased cumulative dose of first generation PI bortezomib significantly improved overall survival of patients treated with VMP regimen, we studied the effect of cumulative dose of Carfilzomib in RRMM patients receiving KRd. Results: Clinical and demographic characteristics of patients included in the study are summarized in Table 1. Median age was 65 years (range 33-86), most patients were males (54%). About half of the patients included in the survey were refractory to previous treatment (54%); Sixty-five (63%) patients received at least 5 cycles of KRd and 38 (36%) received at least 10 cycles. Overall response rate was 34% (35 patients); 18 patients (17%) achieved a complete response (CR), 6 patients minimal response (MR), 13 (12%) patients achieved PR, 16 patients achieved MR and then progressed; progression occurred in 20 patients, among them 3 did not reached any response. Delays due to adverse events were 33%, mainly due to febrile neutropenia (22%), thromboembolic events (4.5%), heart failure (3%), or thrombocytopenia (4.5%). To prevent hematological toxicities, 24% of patients received granulocyte growth factors, 15% erythropoietin. In 30 patients treatment was reduced (mainly due to lenalidomide toxicity) and in 5 patients discontinued for toxicity. Thus, median cumulative carfizomib doses at 2, 3, 4 and 6 cycles were respectively 480 mg (282 mg/m2), 735 mg (435 mg/m2), 995 mg (589 mg/m2) and 1522mg (890 mg/m2). After a median follow up of 16.2 months, PFS at 12 months was 67.3%. We found that median PFS was significantly longer in patients who received at least 480 mg (282 mg/m2) within first two months of treatment compared to those that could not receive full-dose KRd (respectively, undefined vs 11 months p=0.04). To identify patients that could obtain the most advantage by KRd treatment, 65 patients who had received at least six cycles were distinguished in two groups, based on previous treatments. In group A, 27 patients were heavily pretreated (median previous lines 4, range 2-10) and had previously received lenalidomide while 38 patients included in group B were less pretreated (median previous lines 3, range 1-5) and lenalidomide- naïve. We found that group A had lower PFS than group B although duration of PFS from the previous treatment was similar in both groups. Conclusions: In our cohort of patients rate of VGPR or better obtained with KRd combination was high with an overall response rate of 34%, with an acceptable safety profile. It is therefore reasonable that approaches to achieve a higher cumulative dose, such as continuing therapy in responding patients and/or proactive adverse events management, influence efficacy. In addition, it is likely that patients not previously exposed to several lines of treatment including lenalidomide are the best candidate for a favorable outcome with KRd regimen. Disclosures Di Raimondo: Celgene: Honoraria; Takeda: Honoraria, Research Funding.

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A randomized phase III trial of second-line chemotherapy comparing CPT-11 alone versus S-1 plus CPT-11 combination therapy in advanced gastric cancer refractory to first-line therapy with S-1 (JACCRO GC-05).

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.3_suppl.87 ◽

2014 ◽

Vol 32 (3_suppl) ◽

pp. 87-87 ◽

Cited By ~ 2

Author(s):

Kazuhiro Nishikawa ◽

Kazuaki Tanabe ◽

Masashi Fujii ◽

Chikara Kunisaki ◽

Akihito Tsuji ◽

...

Keyword(s):

Response Rate ◽

Progression Free Survival ◽

Line Treatment ◽

Second Line ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Group A ◽

Group B ◽

Line Chemotherapy

87 Background: In East Asia, S-1 + CDDP (SP) has been employed as first-line therapy for advanced gastric cancer (AGC) from the results of SPIRITS trial. Patients who were resistant to chemotherapy with S-1 in the first-line treatment were widely treated with taxane alone or CPT-11 alone as the second-line treatment. On the other hand, the response rate of combination therapy with S-1 is higher than that of CPT-11 alone. Then, we hypothesized that S-1 + CPT-11 prolongs survival in the second-line treatment comparing with CPT-11 alone after failure in the first-line treatment with S-1. (NCT00639327). Methods: Patients with AGC who confirmed disease progression by imaging after the first-line therapy with SP, S-1 + cocetaxel or S-1 alone except S-1 + CPT-11 were allocated into S-1 plus CPT-11 group (Group A) or CPT-11 alone group (Group B) as second-line chemotherapy. Patients who were relapsed to adjuvant chemotherapy with S-1 were not enrolled. Primary endpoint was overall survival, and secondary endpoints were progression free survival, response rate and adverse events. Results: From March 2008 to June 2011, 304 patients were enrolled, and 294 were eligible for analysis. The overall survival was 8.8 months (M) in the Group A and 9.4M in the Group B. There is no statistically significant difference in both groups (P=0.9156). The progression free survival was 4.8M in the Group A and 4.9M in the Group B (P=0.1568). The response rate was 7.6% in the Group A and 7.4% in the Group B. Grade 3 or higher leukopenia, neutropenia and febrile neutropenia were observed more frequently in the Group A than in the Group B. Conclusions: From our results, we do not recommend consecutive use of S-1 as second-line treatment in patients who are refractory to S-1 in first-line chemotherapy. Clinical trial information: 00639327.

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Optimized duration of antituberculosis treatment for managing female genital tuberculosis: real-world experience from a high prevalence region in Eastern China

10.21203/rs.3.rs-55589/v2 ◽

2020 ◽

Author(s):

Jian Sun ◽

Wenjie Wang ◽

Jing Ding ◽

Yusheng Cheng ◽

Yunfeng Zhou ◽

...

Keyword(s):

Side Effects ◽

Response Rate ◽

Complete Response Rate ◽

Complete Response ◽

Single Side ◽

Female Genital Tuberculosis ◽

Group A ◽

Intent To Treat ◽

Group B ◽

Female Genital

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Temsirolimus Has Activity in Non–Mantle Cell Non-Hodgkin's Lymphoma Subtypes: The University of Chicago Phase II Consortium

Journal of Clinical Oncology ◽

10.1200/jco.2010.29.2813 ◽

2010 ◽

Vol 28 (31) ◽

pp. 4740-4746 ◽

Cited By ~ 132

Author(s):

Sonali M. Smith ◽

Koen van Besien ◽

Theodore Karrison ◽

Janet Dancey ◽

Peter McLaughlin ◽

...

Keyword(s):

Follicular Lymphoma ◽

Response Rate ◽

Cell Lymphoma ◽

Single Agent ◽

B Cell Lymphoma ◽

Complete Response ◽

Mantle Cell ◽

Group A ◽

Group B ◽

Indolent Lymphomas

PurposeDespite high initial remission rates, most lymphomas relapse and require further therapy. The mammalian target of rapamycin (mTOR) pathway is a validated target in mantle cell lymphoma, but has not been extensively evaluated in other lymphomas.Patients and MethodsWe performed a phase II trial of single-agent temsirolimus 25-mg weekly in patients with relapsed aggressive and indolent lymphomas. The primary objective was overall and complete response rate. Patients were stratified by histology: group A (diffuse large B-cell lymphoma, transformed follicular lymphoma), group B (follicular lymphoma), and group C (chronic lymphocytic leukemia/small lymphocytic lymphoma, and other indolent lymphomas).ResultsEighty-nine patients were treated, with outcome strongly dependent on histology. Group A had an overall and complete response rate of 28.1% and 12.5%, respectively, and median progression-free survival (PFS) of 2.6 months and median overall survival (OS) of 7.2 months. Group B had overall and complete response rates of 53.8% and 25.6%, respectively, and median PFS of 12.7 months; median OS has not yet been reached. Group C had a partial response rate of 11% with no complete responders. Toxicity was mainly mild and/or reversible myelosuppression and mucositis; however, four patients developed pneumonitis.ConclusionsSingle-agent temsirolimus has significant activity in both diffuse large B-cell lymphoma and follicular lymphoma, although the durability of responses and PFS are longer for patients with follicular lymphoma. This is the first report of substantial activity of temsirolimus in lymphomas other than mantle cell lymphoma, and supports further evaluation of mTOR as a target in these diseases.

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Randomized phase III study of irinotecan and 5-FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): The CRYSTAL trial

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.4000 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 4000-4000 ◽

Cited By ~ 114

Author(s):

E. Van Cutsem ◽

M. Nowacki ◽

I. Lang ◽

S. Cascinu ◽

I. Shchepotin ◽

...

Keyword(s):

Response Rate ◽

Performance Status ◽

Phase Iii ◽

Line Treatment ◽

First Line ◽

Ecog Performance Status ◽

Skin Reactions ◽

Group A ◽

Group B ◽

First Line Treatment

4000 Background: Cetuximab in combination with irinotecan-based regimens has proven activity in previously-treated patients (pts) with mCRC. The present trial investigated the effectiveness of cetuximab in combination with standard FOLFIRI compared with FOLFIRI alone in the first-line treatment of pts with epidermal growth factor receptor (EGFR)-expressing mCRC. Methods: Pts were randomized 1:1 to receive either cetuximab (400 mg/m2 initial dose then 250 mg/m2/week [w]) plus FOLFIRI q 2 w (irinotecan 180 mg/m2, FA 400 mg/m2, 5-FU bolus 400 mg/m2, 5-FU infusion 2,400 mg/m2 over 46 hours) (Group A) or FOLFIRI alone (Group B). The primary endpoint was progression-free survival (PFS), with secondary endpoints of overall survival (OS), response rate (RR), disease control rate and safety. 633 events were required to statistically differentiate PFS between groups with 80% power. Results: Between August 2004 and October 2005, 1,217 pts were randomized, 608 to Group A and 609 to Group B (60% male, median age 61 [19–84], ECOG performance status: 0=54%; 1=43.5%; 2=3.5%). Median PFS was significantly longer for Group A compared to Group B (8,9 months [8 - 9,5] for Group A vs. 8 months [7.6 - 9] for Group B, p=0.036). Response Rate was also significantly increased by cetuximab (46.9% vs. 38.7%, p=0.005). Treatment was generally well tolerated with neutropenia (26.7% Group A, 23.3% Group B), diarrhea (15.2% and 10.5% respectively) and skin reactions (18.7% and 0.2% respectively) being the most common grade 3/4 adverse events. Conclusions: Cetuximab in combination with FOLFIRI significantly increases response rate and significantly prolongs PFS in the first-line treatment of pts with mCRC, reducing the relative risk of progression by approximately 15%. Treatment-related side effects of cetuximab in combination with FOLFIRI were as expected, with diarrhea being moderately and skin reactions significantly more frequent as compared to FOLFIRI alone. [Table: see text]

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Carboplatin (C) plus paclitaxel (P) versus carboplatin plus pegylated liposomal doxorubicin (PLD) in patients with advanced ovarian cancer (AOC): Final analysis of the MITO-2 randomized multicenter trial.

Journal of Clinical Oncology ◽

10.1200/jco.2010.28.18_suppl.lba5033 ◽

2010 ◽

Vol 28 (18_suppl) ◽

pp. LBA5033-LBA5033 ◽

Cited By ~ 5

Author(s):

S. Pignata ◽

G. Scambia ◽

A. Savarese ◽

R. Sorio ◽

E. Breda ◽

...

Keyword(s):

Ovarian Cancer ◽

Response Rate ◽

Multivariable Analysis ◽

Advanced Ovarian Cancer ◽

Final Analysis ◽

Phase Iii ◽

P Value ◽

First Line ◽

Significant Difference ◽

Line Chemotherapy

LBA5033 Background: CP is standard first-line chemotherapy for AOC. MITO-2 (Multicentre Italian Trials in Ovarian Cancer) is an academic multicenter randomized phase III study, testing whether C-PLD is more effective than CP. Methods: AOC chemo-naïve patients (pts), stage IC-IV, aged≤75, ECOG PS≤2, were randomized to CP (C AUC5 + P 175 mg/m2,d1q3w) or to C-PLD (C AUC5 + PLD 30 mg/m2,d1q3w), both for 6 cycles. Primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), response rate, toxicity and quality of life (QoL). To have 80% power in detecting a 0.80 HR in PFS, with 2-sided α error 0.05, 632 events were needed and 820 pts were planned. Response rate and toxicity have been reported at ASCO 2009 (abs #LBA5508). All analyses are based on intention to treat. Results: From Jan ’03 to Nov ’07, 820 pts were randomized, 410 to each arm. Median age was 57 yrs (range 21-77). Stage III (60%) and IV (21%) were prevalent. A plateau in PFS events was reached before obtaining the planned number. Thus, following an IDMC recommendation, the final analysis was done with 556 events occurred as of December 31, 2009. This size is consistent with HR to be detected equal to 0.79, with 80% power. With a median follow-up of 40.2 months, median PFS was 19.0 and 16.8 months with C-PLD and CP, respectively (HR 0.95, 95%CI 0.81-1.13, log-rank p value=0.58). Lack of significant difference was confirmed (HR 0.96, 95%CI 0.81-1.14) at multivariable analysis adjusted by stage, PS, residual disease, age and size of the institution. There was no heterogeneity of treatment effect among major subgroups. With 313 deaths recorded, median OS was 61.6 and 53.2 months with C-PLD and CP, respectively (HR 0.89, 95%CI 0.72-1.12, log-rank p value=0.32). QoL data will be presented at the meeting. Conclusions: In the MITO-2 trial, C-PLD was not found to be superior to CP, which remains the standard first-line chemotherapy for AOC.However, given the observed confidence interval and the different toxicity profile, C-PLD could be considered an alternative to standard therapy. Study was partially supported by Schering-Plough. [Table: see text]

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LDH serum levels as prognostic and predictive factor in advanced biliary tract cancer patients treated with first-line chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.313 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 313-313

Author(s):

Luca Faloppi ◽

Michela Del Prete ◽

Mario Scartozzi ◽

Daniele Santini ◽

Maristella Bianconi ◽

...

Keyword(s):

Cancer Patients ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Serum Levels ◽

First Line ◽

Tract Cancer ◽

Group A ◽

Group B ◽

Line Chemotherapy

313 Background: Previous data suggested that LDH serum levels may be associated with tumour hypoxia and VEGFA and VEGFR-1 over-expression. LDH may then represent an indirect marker of activated tumour neo-angiogenesis and worse prognosis in many tumour types. In our analysis, we analyzed the role of LDH serum levels in predicting clinical outcome for biliary tract cancer patients treated with first-line cisplatin and gemcitabine chemotherapy, to individuate a potentially reliable and easy to use marker for patients stratification. Methods: 71 advanced biliary tract cancer patients treated with cisplatin and gemcitabine in first-line chemotherapy were available for our analysis. For all patients, LDH values were collected within one month before treatment beginning. We chose the laboratory cut-off (Upper Normal Rate, UNR) as LDH cut-off value (450 U/l) and then we divided the patients into two groups (A and B, below and above the UNR respectively). Survival distribution was estimated by the Kaplan-Meier method. Disease control rate (DCR) was assessed with chi-square test. A significant level of 0.05 was chosen to assess the statistical significance. Results: Patients in group A (46 patients) and B (25 patients) proved homogeneous for all clinical characteristics analyzed. Median progression free survival (PFS) was 3.97 months and 1.8 months respectively in group A (patients with LDH level below the UNR) and in group B (patients with LDH level above the UNR), p=0.0064 (HR=2.07, 95%CI: 1.07-3.99). Median overall survival (OS) was 9.24 months and 2.55 months in group A and B respectively, p<0.0001 (HR=2.93; 95%CI: 1.37-6.27). DCR was 65% in group A vs. 21% in group B (p=0.004). Conclusions: Our observations seem to suggest a prognostic role of LDH in biliary tract cancer patients. Our findings showing an improved PFS and DCR in patients with low LDH serum levels also suggest a possible predictive role in patients treated with a cisplatin and gemcitabine regimen as first-line chemotherapy. After further confirmation in larger trial, these results may be relevant for a better patients stratification and selection.

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