Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study.

BACKGROUND: Treatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice. METHODS: Retrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients' clinical characteristics. RESULTS: All 210 eligible patients had a median age of 65.0 years (range 37-81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status ≥2. Patients received a median of four cycles of treatment (range 1-21), with a median duration of 3.5 months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2 months (95% CI 6.0-8.5), and median PFS was 5.0 months (95% CI 4.3-5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age ≥ 70 years and/or the presence of hepatobiliary stent or RDI < 85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0-1 vs. 2-3 (p = 0.030), baseline NLR > 3 vs. ≤ 3 (p = 0.043), and baseline CA 19.9 > 37 U/mL vs. ≤37 U/mL (p = 0.004). CONCLUSIONS: Nab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed.

Toxicity Associated with Capecitabine in Patients Suffering from Dihydropyrimidine Dehydrogenase Deficiency.

Dihydropyrimidine dehydrogenase (DPD) is a metabolic enzyme that is crucial in 5-fluorouracil (5-FU) degradation. A deficiency in it is associated with the occurrence of adverse events following fluoropyrimidine-based therapies. We describe a case of toxicity grade 5 after the administration of capecitabine and oxaliplatin in a patient with stage III colorectal cancer and DPD congenital deficiency, which was identified later. Several polymorphisms have been associated with the global toxicity of 5-FU; however, genetic tests are low in sensitivity and therefore they cannot as yet be used as prescreening techniques in clinical practice.

Gemcitabine and vinorelbine followed by weekly docetaxel in patients with advanced non-small-cell lung cancer: a phase II trial of sequential chemotherapy.

UNLABELLED: Objective. We conducted this phase II trial to evaluate the efficacy and toxicity of the sequential nonplatinum combination chemotherapy consisting of gemcitabine (GEM) and vinorelbine (VNR) followed by weekly docetaxel (DOC) in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods. ELIGIBILITY CRITERIA: stage IV NSCLC, Performance status =/< 2, adequate renal, hepatic and bone marrow function. Treatment consisted on: VNR 25 mg/m(2) plus gemcitabine 1000 mg/m(2), on days 1 and 8 of each 21-day cycle, followed by docetaxel 36 mg/m(2) weekly until progression or unacceptable toxicity. Results. 21 stage IV patients were enrolled. All patients are evaluable for treatment response and toxicity profile. The mean age of the patients was 63 years (range: 51 to 72) with 18 (86%) males and 3 (14%) females. Histology types were: adenocarcinoma in 8 patients (38%), large cell carcinoma in 1 patients (5%) and squamous cell carcinoma in 12 patients (57%). The majority of the patients had and ECOG PS of 1. Eight patients (38%) did not complete six cycles of gemcitabine-navelbine. The median number of cycles of gemcitabine-navelbine was 4 (range 2-6) Of the 13 patients (61%) who completed six cycles of gemcitabine-navelbine, all of them went on to receive weekly docetaxel and received at least 3 cycles, with a median number of 8 cycles (range 3- 16). The overall response rate was 33%. Respect survival, the minimum follow-up was 6 months (range, 6-25 months). The median survival time (MST) was 7.9 months, and the 1-year survival was 30%, and the median progression-free survival was 4.7 months. Toxicity was mild, well tolerated and mostly hematologic. In the GEM/VNR cycle, grade 3/4 neutropenia occurred in 14%, two patients with febrile neutropenia. Grade 3 anaemia in 1 patients (5%) and grade 3 thrombocytopenia in 1 patient (5%). Nonhematologic toxicity was also mild: 1 patient with Grade 3 skin toxicity with docetaxel, 1 patient with grade 3 infection, 2 patients with grade 3 astenia and 1 patient with a mild allergic reaction postchemotherapy treatment with docetaxel. Conclusion. The sequential triplet nonplatinum chemotherapy consisted of GEM/VNR followed by weekly DOC is active and can be administered safely in advanced NSCLC. Our results are similar with other sequential regimens and did not represent a significant improvement in the treatment of this disease.

Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study

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Backbround. In this Phase I/II trial, the maximumtolerateddose (MTD) and activity of cisplatin plusvinorelbine (VRL) administered in continuous infusionas first-line treatment of advanced non smallcell lung cancer (NSCLC) was determined in 12consecutive chemotherapy-naive patients with advancedNSCLC.Patients and methods. The dose of cisplatin was100 mg/m2 in all patients, and vinorelbine was administeredas an initial intravenous (iv) bolus of 8mg/m2 on day 1 followed by a 4-day continuous ivinfusion at 4 different 24 h dose levels (DLs) to berepeated every 21 days. All 12 patients (47 cycles)were evaluable for response and toxicity.Results. The MTD was 8 mg/m2 bolus followed by acontinuous iv infusion of 8 mg/m2 per day over 4days. The dose limiting toxicities (DLT) were febrileneutropenia in 4 patients and grade 3 mucositis in 1patient. There was less neuro-toxicity and comparedto the weekly bolus scheme. There was nosignificant cumulative toxicity after 3 cycles. Partialresponses were observed in 6 patients; an overall responserate of 50% (95% CI: 30-65%). Median time toprogression was 5,5 months (95% CI: 1,5-11 months)and median survival was 11 months (95% CI: 5-20months).Conclusions. The results demonstrate that, in thissetting of first-line treatment of NSCLC, cisplatinplus vinorelbine at 8 mg/m2 bolus followed by acontinuous infusion of 8 mg/m2 per day over 4 daysis the recommended schedule. Further trials wouldbe useful to establish activity of this combination

Solitary metastasis in a nasal fossa as the first manifestation of a renal carcinoma.

Renal cell carcinoma is an uncommon tumor in adults. Metastasis in the nasal fossa is rare, and can become apparent as a result of repeated epistaxis. We report a patient with renal cell carcinoma presenting with epistaxis secondary to a metastasis in the right nasal fossa. The primary tumor was treated with nephrectomy and the nasal fossa metastasis was treated successfully with embolization, chemoimmunotherapy, surgery, and radiotherapy. The presence of repeated epistaxis may very occasionally be the first symptom of renal cell carcinoma, and systemic treatment combined with local treatment may enable adequate control of the disease.

Solitary metastasis in a nasal fossa as the first manifestation of a renal carcinoma

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Renal cell carcinoma is an uncommon tumor inadults. Metastasis in the nasal fossa is rare, and canbecome apparent as a result of repeated epistaxis.We report a patient with renal cell carcinoma presentingwith epistaxis secondary to a metastasis inthe right nasal fossa. The primary tumor was treatedwith nephrectomy and the nasal fossa metastasiswas treated successfully with embolization, chemoimmunotherapy,surgery, and radiotherapy. Thepresence of repeated epistaxis may very occasionallybe the first symptom of renal cell carcinoma, andsystemic treatment combined with local treatmentmay enable adequate control of the disease

Bronchiolitis obliterans organizing pneumonia simulating progression in bronquioloalveolar carcinoma

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Bronchiolitis obliterans organizing pneumonia(BOOP) is a clinicopathologic syndrome withcharacteristic features. The diagnosis of BOOPrequires the presence of a combination of pathological,clinical, and radiological features. We reportthe case of a lung cancer patient with bronquiloalveolarcarcinoma (BAC) presenting withBOOP after chemotherapy with docetaxel andgemcitabine producing severe respiratory insufficiency,and simulating a progression of the tumor

Subcutaneous metastasis as the first manifestation of a solid-pseudopapillary tumor of the pancreas

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Secondary signet-ring cell tumour of the prostate derived from a primary gastric malignancy.

Primary signet-ring cell carcinoma of the prostate is infrequent and even more so as secondary spread of this pathologic sub-type to the prostate. We describe the sixth reported case with a diagnosis of a secondary signet-ring cell tumour of the prostate secondary to a gastric cancer. Five years post-gastrectomy to resect signet-ring cell carcinoma, we detected a secondary intra-prostatic spread with urinary tract obstruction. The physical appearance of the tumour cells was similar to that of the previously-resected signet-cell carcinoma of the stomach. There were no metastases in other sites and the patient was treated with radiotherapy. When confronted with intra-prostatic signet-ring cell adenocarcinoma it is necessary to distinguish between primary and secondary aetiology since this would reflect in the choice of treatment and prognosis.

Secondary signet-ring cell tumour of the prostate derived from a primary gastric malignancy

Primary signet-ring cell carcinoma of the prostate is infrequent and even more so as secondary spread of this pathologic sub-type to the prostate. We describe the sixth reported case with a diagnosis of a secondary signet-ring cell tumour of the prostate secondary to a gastric cancer. Five years post-gastrectomy to resect signet-ring cell carcinoma, we detected a secondary intra-prostatic spread with urinary tract obstruction. The physical appearance of the tumour cells was similar to that of the pre-viously-resected signet-cell carcinoma of the stomach. There were no metastases in other sites and the patient was treated with radiotherapy. When confronted with intra-prostatic signet-ring cell adenocarcinoma it is necessary to distinguish between primary and secondary aetiology since this would reflect in the choice of treatment and prognosis