Clinical study for Advanced Pancreas Cancer treated by Oncothermia

Probability Overall survival

Probability of survival

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Summary

Presented are clinical studies of pancreas cancer (PCA), an aggressive and common tumour. The studies took place in two centers and both made the treatments by oncothermia combined with the conventional therapies. The final results show an exceptional survival benefit for the patients in comparison to historical data and the feasibility of the oncothermia treatment of PCA.

Introduction

The study involved patients of an average age of 64.5 years old (37 – 77), the mean-age was 62.5 years old. Everybody received at least one chemotherapy and most of them underwent surgery.

23 patients [88.5%] were in advanced [WHO III or IV] stages, and at the first oncothermia treatment in 100% of the cases was in advanced stages, 19 patients (73.1%) were in the worst stage.

Methodology

The present results are obtained from an open-label, single-arm, retrospective study. The involved patients are being analyzed according to an intention-to-treat (ITT) schedule. The primary check of the efficacy of a curative method in such a lethal kind of disease is the survival time. The primary endpoints of the present study therefore were the overall survival oncothermia treatment time (OS) and the survival time from the first oncothermia treatment (oncothermia treatment survival time, OSO). The date of death (or alive) was checked so the actual and accurate data were collected.

In order to support the reliability of the retrospective data set, two independent hospitals were involved in the present study. One is the Peterfy Hospital, Budapest (PFY). It is a governmental hospital involved in the regular health-service network. The other one is a private day-clinic (HTT- Med Polyclinics, (HTT)), serving the patients only on private basis.

The median age was 64.5 years old (37 – 77), the mean-age was 62.5 years old. Everybody received at least one chemotherapy and most of them underwent surgery. 23, [88.5%] was in advanced [WHO III or IV] stages, and at the first oncothermia treatment 100% was in advanced stages, 19 (73.1%) were in the worst stage.

Patients were dominantly in late/advanced stages, where the traditional oncotherapies were unsuccessful.
Inclusion criteria were: (1) Inoperable or sub-totally resected or recurrent primary pancreas tumor, (2) progression after surgery and/or chemotherapy, (3) Karnofsky Performance Score (KPS) > 40%. and the inclusion was irrespective of the localization of the lesion in the pancreas. Most of the patients failed to respond to any of the applied conventional therapies.

Treatment

The oncothermia treatment was provided 2-3 times a week, the treatment number was in average 9.0 (st.err.0.86) and its median 6 (3-16).

Results

Safety and adverse events:

The Kaplan-Meier plots of the overall survival (OS) (median 12.0 months, [2.3-115.5]; mean 17.5 months, and the survival from the first oncothermia treatment (OSO) median 6.32 months; mean 8.9 months.

HTT-MED Polyclinic (HTT) (n=73)
Patients CharacteristicsThe age-distribution of n=73 patients was near to normal; no outlier was present. The median age was 58 years old (24 – 79), the mean-age was 59.1 years old. They were heavily pretreated, mostly (93.4%) underwent surgery and subsequent radiation and/or chemotherapies, the actual staging was made at the first diagnosis (45, 61.6% was in advanced [WHO III or IV] stages) and at the first oncothermia treatment they were in more advanced status.

Treatment
The oncothermia treatment was provided twice a week, the treatment number was in average 8.0 and its median 6 (3-26). The equivalent temperature in average was 50.7, median 51 (43-59). The applied treatment time in average was 67.2 minutes, and its median was 60 (45-120).

Results
The Kaplan-Meier plots of the overall survival (OS) median 12.7 months, [1.2-94.5]; mean 19.2 months, and the survival from the first oncothermia treatment (OSO) median 4.7 months, [0.3- 49.2]; mean 12.6 months.

Conclusion

This paper indicates the feasibility of the oncothermia treatment of PCA. The results are well indicating the benefit of treating PCA by oncothermia:

1. Oncothermia was applied for pancreas tumors, showing a valid treatment potential and safe application.
2. No safety or notable toxicity problem has occurred. The development of an edema or burn, which was a complication of hyperthermia applications in the past, is not the case with oncothermia. The treatment is safe and convenient to use.
3. The survival time, as one of the most important parameters, was increased for the patients making progress by other treatments.
4. The quality of life of the patient was improved by oncothermia according to their subjective reports.

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Scientific article publishing date : 1/9/2012

Immucura identifier : BSC21_041EN

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