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Enfermería Global
versión On-line ISSN 1695-6141
Enferm. glob. vol.16 no.47 Murcia jul. 2017 Epub 01-Jul-2017
https://dx.doi.org/10.6018/eglobal.16.3.260351
Originales
Main complications associated with the administration of intraperitoneal and intravenous chemotherapy in ovarian cancer patients
1Diploma in Nursing. Institut Clínic de Malalties Hemato-Oncològiques (ICMHO), Hospital Clínic de Barcelona. Spain.
2Graduated in Nursing. Institut Clínic de Malalties Hemato-Oncològiques (ICMHO), Hospital Clínic de Barcelona. Spain.
Background
Ovarian cancer displays the highest death rates amongst all gynaecologic cancers. Most cases are diagnosed at an advanced stage of the disease and the treatment of choice is generally the combination therapy of intraperitoneal (IP) and intravenous (IV) chemotherapy. While this approach has been shown to prolong survival, multiple associated toxicities have been reported.
Objective
To identify the side effects and complications resulting from IP+IV chemotherapy treatment in stage III and stage IV ovarian cancer patients during the 2007-2015 period.
Methods
A descriptive, longitudinal and retrospective study was performed. A group of 17 women diagnosed with stage III and stage IV ovarian cancer were treated with IP+IV chemotherapy in Hospital Clínic de Barcelona during the period 2007-2015.
Results
Of the 17 patients who were treated with IP+IV chemotherapy, only 5 (29,41%) completed the 6 cycles of treatment. Notably, 12 (70,58%) patients discontinued the treatment due to a series of complications, which were frequently associated with IP reservoir and psychological disorders. The most commonly reported side effects were asthenia, neurotoxicity and abdominal pain.
Conclusions
The majority of patients discontinued their prescribed therapy due to complications associated with IP reservoir and psychological disorders. We believe that the nurse plays a key role, not only in managing the technical aspects of the therapy but also in providing patients with emotional support throughout their journey.
Keywords: Intraperitoneal chemotherapy; nursing care; ovarian cancer; adverse effects; complications; toxicity
INTRODUCTION
Ovarian cancer is the most common cause of death on women that develops malign gynaecologic tumor1. From epidemiologic information of “Sociedad Española de Oncología Médica” (SEOM) in 2012, in Spain it is the fifth most common neoplasm in feminine population with a 3.7% of incidence and a 4.8% of mortality2.
5-10% of ovarian cancers are inherited as a mutation of genes BRCA1 and BRCA2. As any other malign tumour, the accumulation of genetic disorders are the cause of the uncontrolled growth and proliferation of epithelial cells, unknowing the mechanism that induce such disorders3.
This neoplasm is the most frequent in postmenopausal woman, with a maximum incidence between the ages of 50-75. More than 75% of the cases are diagnosed in an advanced stage of the illness (stage III-IV)1)(4) worldwide, and this affects in causing peritoneal involvement and an elevated mortality in patients. Mortality increasement is explained by two reasons:
The absence of initial specific symptoms so the majority of patients present a disseminated disease in the diagnostic moment which is more difficult to cure
The absence of early detection methods such as screening which are efficient and validated
In these cases Intraperitoneal Chemotherapy (IP) is an appropriate treatment as it allows giving a higher concentration of cytotoxic drug into tumour mass, a drug’s average life higher in comparison with intravenous (IV) administration and the consequent reduction of systemic toxicity 4)(5)(6)(7)(8.
Ideal cytoreduction surgery of the tumour (less than 1 cm) constitutes the first line treatment. During this procedure a one-lumen intraperitoneal catheter is introduced and implanted in right or left quadrant of the abdomen, which is tunnelled up to peritoneal cavity7. Afterwards, this catheter is used for IP chemotherapy administration with Cisplatin and Paclitaxel1.
Several studies show the use of IP chemotherapy increases up to 12 months the survival of patients with ovarian cancer and optimally removed tumour in relation to exclusive IV treatment with chemotherapy4)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15. Despite that fact, IP chemotherapy causes a higher number of toxicities grades 3 and 4 at all levels and a worse tolerance that ends up to an appreciable number of cases with an interruption of the IP treatment 7.
The first reference of IP chemotherapy appears in the 1950’s as a treatment against malign ascitis16. Recently several clinical trials, which support the use of this treatment, have been made 13)(17)(18.
The IP chemotherapy treatment diagram that is being used in Hospital Clínic of Barcelona is divided into 6 cycles. Each cycle consist on administration of Paclitaxel IV 1st day (135mg/m2) during 3 hours, Cisplatin IP 2nd day (100mg/m2) and Paclitaxel IP 8th day (60mg/m2) every 21 days.
IP chemotherapy is administered through a subcutaneous reservoir which we have described beforehand5. It is recommended that handling and administration of saline solution through the reservoir must be done by a specialized nurse. During IP chemotherapy and IP administration of saline solution (body temperature)17 the patient must be absolutely resting in supine and semi-fowler position 5)(17)(19. The administration of the treatment will always be by gravity force19 regardless of the catheter gauge we used to prick subcutaneous reservoir. Once IP administration has finished it is necessary for the patient to carry out postural changes from right to left lateral position every 15 minutes during 1 hour. This way equitant distribution of chemotherapy is done thorough the whole peritoneal cavity 5)(19.
OBJECTIVES
Our objectives in this study are:
General:
To identify side effects and main complications resulting from IP chemotherapy treatment in patients that have been diagnosed of advanced ovarian carcinoma from stage IIIC on and that have been treated in Hospital Clínic of Barcelona during the period between 2007-2015.
Specific:
METHODS
It is a descriptive, longitudinal and retrospective study. A group of 17 women diagnosed of stage III-IV ovarian cancer and that have received IP chemotherapy in Hospital Clínic of Barcelona between 2007-2015 have been studied.
Investigation project was submitted to our Hospital Clinic Investigation Ethics Comitee (CEIC) being passed on February 2016. This project does not pose any ethical conflict as no direct intervention has been made. All necessary information was compiled from our hospital data base (SAP) by clinical records written up until now. This is the reason why it is not necessary any informed consent.
Medical and patients’ information has been exclusively used as study aim, so have been preserved confidentially as establishes organic law 15/1999 of personal information protection.
Information obtained from patients’ clinical records are: age when the diagnosis was made, stage of illness, IP chemotherapy dose that has been administered, reason for treatment stoppage, side effects during and post administration and if any reduction of doses has been made.
Regarding study limitations, as a consequence of the incomplete clinical records, some troubles in key information gathering were detected such as side effects or tolerance during IP chemotherapy administration.
RESULTS
A total of 17 patients with ages between 29 and 66 years old (being the median 50 years old) received IP chemotherapy treatment.
5 patients (29.41%) ended all 6 cycles of the treatment, which consists on IP + IV chemotherapy and 12 patients (70,58%) didn’t get to complete them.
From all patients included in this study, 4 of them (23,52%) needed a reduction of IP Cisplatin dose. From this group, 1 patient (25%) completed all cycles and the reminder ones (75%) stopped the treatment; 2 of them because of psychological disorder and 1 for presenting hypomagnesaemia. (Figure 1). The reason why these 4 patients doses had to be reduced was haematological toxicity in one of them and intestinal toxicity in 3 patients.
During IP administration, 8 patients (47%) referred abdominal pain or discomfort, which was solved by reducing infusion speed or administering IV analgesic.
Additionally, most frequent side effects post-administration of IP+IV chemotherapy which patients presented were asthenia, neurotoxicity, abdominal pain and diarrhoea (Table I).
Side effects | N | % |
---|---|---|
Asthenia | 13 | 76,47 |
Neurotoxicity | 7 | 41,17 |
Abdominal pain | 7 | 41,17 |
Diarrhoea | 6 | 35,29 |
Nauseas | 5 | 29,41 |
Constipation | 4 | 23,52 |
Anxiety | 4 | 23,52 |
Haematological Toxicity | 4 | 23,52 |
Complications that made patients stop IP treatment were most of them associated with IP reservoir and psychological disorder (Table II).
Cause of stoppage | N | % |
---|---|---|
IP reservoir complications | 4 | 33,33% |
Psychological disorders | 3 | 25% |
Abdominal clinics | 2 | 16,66% |
Electrolytic disorders | 2 | 16,66% |
Impervious to Cisplatin | 1 | 8,3% |
Main cause of stoppage was associated with IP subcutaneous reservoir in contrast to impervious to Cisplatin as the one with less incidence rate.
From all IP chemotherapy programmed doses (N=204; 12 doses per patient) a total of 126 were administered which means 61,76% from the total.
DISCUSSION
The combination of IP and IV chemotherapy increases survival in advanced ovarian cancer diagnosis in comparison with exclusively IV administration13.
In spite of this clinical advantage, this study highlights the appearance of complications and side effects related with IP+IV chemotherapy that obliged them to stop before reaching the total number of planned cycles.
Comparing this study with modified GOG-172 trial, which uses the same treatment diagram, we observe that the percentage of patients that ended the treatment was 29% in comparison with 42% of GOG-172 trial 8)(15)(19)(20) and 58% from SWOG 85018 trial. We must take into account the difference between samples with 17 patients versus 415.
An important limitation in this study is the lack of patients sample treated in only one centre, so multicentre studies would provide statistical significant results.
On the other hand, the number of patients who receive this treatment per year in Hospital Clínic of Barcelona has increased, so there is a possibility to include a higher number of patients in future studies and, as a result, a new evaluation on associated complications.
One of the measures taken to reduce significantly hematologic and intestinal toxicity is changing the dose, especially with IP Cisplatin, which has considerable systemic toxicity1. This implies a growth of patients who end the treatment although survival rate can be not that successful.
Most frequent side effect observed in this study is asthenia; which can also be affected by other factors like surgery, pain, sleep disorder, anaemia, gastrointestinal disease and emotional distress. These results agree with the ones obtained in other studies (Herben et al., 1999; Holzner et al., 2002; Holzner et al., 2003; Payne, 2002; Terauchi et al., 2003)21.
Other detected side effects were neurotoxicity and abdominal pain, which were also described in GOG-172 trial8.
The main reason to stop the treatment was related to IP reservoir, which agrees with results obtained in Walker et al., 2006 trial and problems detected as partitioning, infection, extravasation and rotation1)(13)(22. We must take into account psychological disorders that 3 of our patients presented and derived in treatment stoppage. This fact denotes the need to improve in technical aspects and emotional support related with professional assistance.
Previous results conclude in the importance to count on oncology-trained nurses and with experience in IP chemotherapy administration. Procedures like needle positioning in IP reservoir applying local external anaesthesia beforehand or placing patient in semi-fowler position on bed5 to improve breathing during treatment, are essential to improve assistant quality.
Establishment of nursing examination room would be essential to provide support to physical and emotional needs from patients and their families. These consultations should deal with key aspects as information about disease, IP reservoir, type of chemotherapy to administer and its possible toxicities. This way, professional monitoring would decrease emotional impact and anxiety.
CONCLUSIONS
Not all patients who suffer from ovarian carcinoma and receive treatment with IP+IV chemotherapy succeed in ending all cycles, mainly because of complications related to IP reservoir and psychological disorders. A trained nursing team is needed in management of technical aspects and able to educate and inform patients and their families to relieve anxiety and to provide full assistance.
Taking into account the reasons described beforehand, oncologic nurses should consider their procedures in this kind of treatments as they need a decrease in the number of patients who do not end IP chemotherapy cycles.
FUTURE EXPECTATIONS
These results can help to develop future standardized procedure diagram as more knowledge about this therapy is given and patients’ care would improve.
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Received: June 04, 2016; Accepted: August 30, 2016