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Hamburg, Germany

Richter E.,Compound and Care Pharma GmbH | Denecke A.,Compound and Care Pharma GmbH | Klapdor S.,Compound and Care Pharma GmbH | Klapdor S.,ZeTDT GmbH | And 2 more authors.
Anticancer Research

Background: Malnutrition is a frequent and serious problem of patients with pancreatic cancer (i.e. due to exocrine pancreatic insufficiency, postoperative syndromes, anorexia, chemotherapy, and/or tumor progression). In many cases it has negative effects on the quality of life or on the tumor therapy. We investigated if malnutrition can be resolved or corrected by adequate home parenteral nutrition (PN) of pancreatic cancer (PaCa) patients, in cases where dietary advice and oral nutrition supplementation failed to correct the deficiencies. The energy supply via PN was analyzed in patients with PaCa, with focus on the single components in compounded PN. Patients and Methods: We examined a group of six women and eleven men with assured PaCa disease at different tumor stages (mean age: 64 years). Indications for PN were a reduction of body weight of >5% in three months and/or a long-term reduced nutritional status, reduced results of the bio-electrical impedance analysis (BIA), malassimilation and/or clinical symptoms like severe diarrhoea/vomitus, preventing adequate oral nutrition for weeks. The PN, administered via portcatheter, was initiated while the patients were undergoing chemotherapy. The course of treatment was assessed based on body weight, BIA (Data-Input Nutriguard-M), on laboratory parameters and on personal evaluation of the patients' quality of life. Retrospectively, the patients were subdivided into two groups (Gr): Gr1 (n=10) had a survival period of more than 5, up to more than 37 months, after the start of PN and Gr2 (n=7) had a survival between 1-4 months after start of PN. The calculations of the energy supply were based on the patients' body weight (per kg). Fluid volume, relation of macronutrients and addition of fish oil to PN are described in detail. Results: Gr1: Eight of ten patients already showed an increase of body weight with the initial PN, two patients after dose adaption. This positive impact was also observable on the cellular level by means of BIA results (phase angle, body cell mass (BCM), extracellular mass (ECM), cell content and ECM/BCM Index). Two patients, who were receiving PN for over two or three periods, showed reproducibility of the results; while when PN was interrupted all BIA parameters degraded and they ameliorated with the restart of PN. Gr2: In these patients PN was started in the late stage of the tumor disease in order to allow for a - from the retrospective point of view - last, but ineffective chemotherapy. The data indicated that the weight loss could be retarded, even if the effects on body weight and BIA parameters were found to be less pronounced compared to Gr1. The mean energy supply of both groups, however, was similar: 8,823 kcal (Gr1) per week compared to 9,572 kcal (Gr2) per week. The majority of patients claimed to be quicker and more powerful under PN and to some extent the appetite was enhanced. Conclusion: A timely onset of PN with sufficient calories leads to an improved nutritional status of patients with PaCa disease. PN enhances the quality of life, the administration of tumor therapy without interruption and therefore may lead to a better success of the entire therapy. For late-stage tumor patients (Gr2) the quality of life can, at least, be improved. The success of PN is significantly dependent upon the patients' compliance, which could be achieved through intensive consulting and support of all patients and their relatives. Source

Klapdor S.,ZeTDT GmbH | Klapdor S.,Compound and Care Pharma GmbH | Richter E.,Compound and Care Pharma GmbH | Klapdor R.,ZeTDT GmbH
Anticancer Research

Exocrine pancreatic insufficiency due to chronic pancreatitis may result -depending on the degree of insufficiency-, in a decrease in serum 25-hydroxyvitamin D (25(OH)D) level. However, the data in the literature concerning the rate and extent of vitamin D deficiency in pancreatic cancer with or without previous pancreas resection, are very rare, in particular regarding the question how to supplement these patients with vitamin D. In recent years, vitamin D is increasingly being discussed as one factor involved not only in musculo-skeletal diseases but also in cardiovascular and autoimmune diseases, cancer development, diabetes mellitus and overall mortality. Patients and Methods: In all, 248 ambulatory patients (n=140 patients suffering from exocrine pancreatic insufficiency due to chronic pancreatitis, pancreatic cancer with/without previous resections of the pancreas n=108 patients without pancreatic disease), we measured the serum 25(OH)D concentrations by the chemoluminescence method. In addition, in 91 of these patients (n=65 pancreatic patients, n=26 controls), we started supplementation with oral vitamin D in combination with dietary advice and adequate substitution with pancreatic enzyme preparations, followed by subsequent serum 25(OH)D determinations. The oral vitamin D doses varied from 1000 IU per day over 1x 20000 IU per week, or 2-3 times 20000 IU per week up to 20000 IU per day in single patients, depending on the underlying disease and the estimated degree of maldigestion/malassimilation. In addition, in a pilot trial vitamins A and E were measured in the serum from 121 and 105 of these patients respectively (resp.) (HPLC method). Results: Serum 25(OH)D concentrations were <30 ng/ml in 93% of the patients with pancreatic diseases ,<20 ng/ml in 77.9%, <10 ng/ml in 32.1% and <4 ng/ml in 9.3%. The results were comparable to those in patients suffering from chronic pancreatitis and those with pancreatic tumor disease, with or without a previous tumor resection (n=51 Whipple procedure, n=11 left resection, n=9 total duodenopancreatectomy). Similar data were also found in the controls, only slightly higher. In contrast to the vitamin D data, however, determination of vitamins A and E in the serum resulted in values within the normal range for the majority of the patients of both groups, suggesting a diminished vitamin D uptake as being at least one reason to explain the low serum vitamin D concentrations in the patients with pancreatic diseases. Individual supplementation with oral vitamin D in all patients studied (n=91) resulted in an increase of the serum 25(OH)D concentrations into the normal range (14.2±5.8 up to 42.3±12 in controls, 11.9±7.4 up to 46.6±15.7 in patients with pancreatic diseases). The data of a subgroup of patients with continuous long-term supplementation, however, suggest that some patients with pancreatic diseases may need a significantly higher vitamin D supplementation, up to 20000 IU per day in single patients, compared to the controls. Conclusion: The results demonstrate that vitamin D deficiency is a common problem in patients suffering from exocrine pancreatic insufficiency from various reasons as well as in our controls. Apart from insufficient sun exposure, exocrine pancreatic insufficiency, as well as a too low vitamin D uptake with food seem to represent the main causes of low serum 25(OH)D. In nearly all patients, the serum 25(OH)D concentrations could be normalized by oral supplementation of vitamin D in the case of individual therapy based on routine serum controls. Source

Klapdor R.,Internal Unit | Klapdor R.,ZeTDT GmbH | Klapdor S.,Internal Unit | Bahlo M.,ZeTDT GmbH
Anticancer Research

We report on the results of a prospective treatment of 30 proven metastatic pancreatic cancer patients with the recently described combination of gemcitabine and erlotinib (GEM+E) (24× 1st line therapy, 8× 2nd line therapy). Eight of these patients received GEM+E for treatment of metastastic tumour recurrence after previous resective surgery, followed by adjuvant chemotherapy with gemcitabine. In 2 patients GEM+E was given as 1st line treatment and later, after complete response which was followed by a new recurrence, also as a second line therapy. The evaluation of RASH severity grades, the course of the serum tumour marker CA19-9 were determined every 14 days and the evaluation of the imaging methods CT or MRT, evaluated every 6-8 weeks, revealed the following results: there was a tendency for RASH grades to correlate with the tumour response, however, with observed exceptions. The decision for interruption or maintenance of GEM+E, therefore, should not be based on the RASH phenomenon, but on a detailed follow-up with imaging methods and the relevant tumour markers as in the follow-up before erlotinib introduction into pancreatic cancer therapy. As known from previous studies tumour markers represent more sensitive parameters compared to the imaging methods. GEM+E was active in the whole group of patients, mainly given as 1st line therapy (34% PD, 29% SD, 47% MR, PR, CR), but also in the 2 subgroups: in the patients with GEM+E as 2nd line therapy, as well as in patients after previous adjuvant gemcitabine therapy after tumour resection. In the 2 patients with transient-CR after 1st line therapy with GEM+E the 2nd line therapy also resulted in a CR with long lasting remission. These data should motivate clinicians to focus their interest not only to 1st line therapy regimens with erlotinib, but also to 2nd and 3rd line strategies within the previously published concept of an efficacy-orientated sequential polychemotherapy or multimodal-therapy for pancreatic cancer. Source

Klapdor R.,ZeTDT GmbH | Bahlo M.,ZeTDT GmbH | Babinski A.,ZeTDT GmbH | Klapdor S.,ZeTDT GmbH
Anticancer Research

In order to investigate the use of CA19-9 serum concentration kinetics during first-line chemotherapy of pancreatic cancer as a potential predictive prognostic factor for overall survival, we retrospectively analysed the data of 47 patients suffering from proven exocrine pancreatic cancer. The patients were treated following our concept of efficacy-orientated sequential palliative chemotherapy (EOSPC), on the basis of a short-term follow-up including CA19-9 determinations at least monthly and imaging methods CT and/or MR every 2 months. The results are in agreement with our previous reports suggesting an increase of survival of pancreatic cancer patients in relation to the number of effective treatment regimens applied. However, apart from a weak correlation between the lowest CAI9-9 levels induced by the first-line therapy (as a % of the initial pretherapeutical CA19-9 levels) and progression-free survival there was no correlation between the various parameters of serum kinetics of CA19-9 in the course of the first-line therapy and overall survival of the patients. A potential correlation as reported by others seems to be confirmed in our patient group by the potential antitumoral and life-prolonging effects of the second- and third-line therapies. Source

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