Our outpatient cases for home anti-cancer chemotherapy

We report our outpatient cases for home anti cancer chemotherapy. A total of 97 patients with advanced and recurrent cancer (22 with breast, 20 gastric, 29 colonic, 12 rectal, 1 hepatic, 3 cholangio, 4 pancreatic, 2 duodenal, 2 ovarian and 2 malignant lymphomas) were performed at an outpatient clinic or provided home anti-cancer chemotherapy since December 1996. Of these patients, 9 patients were provided home anti-cancer chemotherapy, 56 patients had died, and 41 patients are alive and undergoing continuous therapy. The response rates revealed effective results in these diseases. No severe side effects were seen, and they underwent treatment at an outpatient clinic easily. The treatment of outpatients for home anti-cancer chemotherapy was effective and maintained the patient's QOL. However, it was important to establish early an exclusive therapy room, training of expert nurses and good staff.     

Evaluation of a totally implanted venous access port and portable pump in a continuous chemotherapy infusion schedule on an outpatient basis

In this study we evaluated the feasibility of a totally implanted vascular access port (VAP) and portable infusion pump for cytostatic drug administration on an outpatient basis, in a 21-day continuous infusion schedule with 4-epidoxorubicin (phase I and phase II study) and mitoxantrone (phase I study). Patients were instructed to dissolve their own drugs at home. Fifty patients were treated with 114 cycles (2394 infusion days). The complication rate was low. In one patient thrombosis of the subclavian and superior caval vein resulted in the termination of treatment. One patient developed pulmonary embolism during treatment. Needle dislocation was observed in two patients. No septicaemia and no irreversible catheter occlusion were seen. Pump functioning was efficient and pump arrest (9 ×) never lasted longer than 24 h. We conclude that a VAP and portable pump are a safe and reliable route of administration for cytostatic drugs on an outpatient basis and that patients are capable of preparing their own drugs at home without increase of complications.     

Home anti-cancer chemotherapy with continuous infusion of 5-FU combined with low-dose cisplatin injection via implantable venous port with portable balloon pump

Home anti-cancer chemotherapy was performed for patients with advanced cancer of the digestive plantable venous port placed beneath the skin via the subclavian vein. 128 patients under 75 years old (enrolled: 6 patients with esophageal, 65 with gastric, 44 with colorectal, 5 with cholangio, 5 with pancreatic, one with hepatic and one with ileal cancer) were treated. Continuous intravenous infusion of 5-FU (300-400 mg/body/day) combined with low-dose injection of cisplatin (5 mg/body/day) was continued for 10 days, and repeated 3 times for 6 weeks. The response rate was 23.6% in 72 patients with valuation of tumor mass. In 83 patients for whom a tumor marker evaluation was also performed, an effect was seen in 30.1%. No severe side effects such as renal dysfunction were observed, and no special infusions were needed. Therefore, a quality of life was maintained in which bathing was possible and patients were released from the hospital. Hyperalimentation through the venous port, and palliation during the terminal stage, is easily accomplished. It is useful method for surgery, chemotherapy and palliative therapy in the treatment of cancer.     

The prospects of the outpatient clinic or home anti-cancer chemotherapy for unresectable recurrence of colorectal cancer

In this study, we analyzed the effectiveness of anti-cancer chemotherapy at the outpatient clinic. We administered CDDP 5 mg/day every 5 days for a week with continuous systemic chemotherapy by 5-FU 500 mg/day for 3 weeks in the hospital, and in the outpatient clinic CDDP 5 mg/day every two days for a week with UFT 300 mg/day orally every day to 145 patients with unresectable recurrence of colorectal cancer. The 50% survival duration after beginning of this chemotherapy was 310.0 days. One-year and 2-year survival rates were 44.4% and 11.7%. One hundred and nine cases were evaluated. The total response rate was 19.3%, and the highest response rate was seen in metastatic lymph nodes (37.5%). The mean duration of continuation of this chemotherapy and the mean duration of staying at home was 188.2 days and 237.8 days. The mean rate of home stays was 68.6%. The group of performance status (PS) 0 or improving PS, accounted for 74.5% of all cases. The occurrence rate of adverse effects was as follows; stomatitis: 17.9%, diarrhea: 11.7% and bone marrow suppression: 13.1%. However, the occurrence rate for cases of grade 3 or 4 was only 1-4%. According to these results, this was an excellent chemotherapy to maintain the patient's QOL from the outpatient clinic.     

Hepatic arterial infusion chemotherapy using totally implantable port system

Because of low grade of response rate and high grade of toxicity, arterial infusion chemotherapy (AIC) is not the first choice therapy for hepatocellular carcinoma (HCC). Only far advanced HCC patients, who have no indication of surgical, transcatheter arterial embolization nor ablation therapy, are able to accept AIC. The AIC using totally implantable port system has an advantage for patient's quality of life in the long term. We recommend new intensive EEP regimen which has the response rate of 43% although its severe toxicity.     

Present and future of home anti-cancer chemotherapy for unresectable recurrence of colorectal cancer

Continuous hepatic arterial infusion chemotherapy (HAI) was performed for 100 colorectal cancer patients with unresectable liver metastases in our outpatient clinic. The administration schedule was 5-FU 250 mg/day for 7 days every other week. In this study, 93 cases were evaluable. The average dose of 5-FU was 24 g (3.0-66.5 g). The response rate was 59.1% (CR: 4 cases, PR: 51 cases, NC: 12 cases and PD: 26 cases). The prognostic outcome was significantly prolonged in the effective cases (50% survival duration was as follows: CR: 764 days, PR: 620 days, NC: 255 days and PD: 152 days). The complication rate with HAI was 15.1%, but nobody died from these complications. Hepatectomy after HAI was performed in 19 cases (20.4%) because of the effect of HAI. The three-year survival rate was 35.3% for HAI with hepatectomy and 3.8% for only HAI. There was statistically significant difference (p < 0.0001) between these two groups. Hepatectomy after HAI is a new strategy for unresectable liver metastasis of colorectal cancer. Recently, we performed home systemic chemotherapy using 5-FU for 3 recurrent patients of colorectal cancer and were able to continue this therapy safely for more than 2 months.     

Trial of outpatient anti-cancer chemotherapy with infusion of 5-FU and cisplatin for advanced gastric and colorectal cancers

We carried out a pilot study on the clinical efficacy and safety of outpatient anti-cancer chemotherapy with 5-FU and CDDP for 5 patients with advanced cancer of the stomach or colon, using two disposable balloon pumps. The protocol was combined chemotherapy with continuous intravenous infusion of 5-FU (500 mg/body/day) and CDDP (10 mg/body/day) in 5-day courses for 1 week, and the therapy was repeated as long as possible. Pharmacokinetic study showed that the mean serum concentration of 5-FU was 64.3+/-9.2 ng/ml, and the serum concentration of total Pt increased continuously during CDDP injection. Thus, both drugs were injected, safely and surely. One patient had a clinically evaluable lesion, and the anti-tumor effect of this case was SD. But the serum CEA level was decreased in 3 cases. The side effect of Grade 3 and 4 was not seen, but nausea, vomiting, anorexia, and weight loss were observed frequently. This therapy enabled the patients to stay home 51.6+/-10.0 days longer than with the usual methods in hospital, and this therapy was thought to improve their quality of life. Thus, this therapy is feasible and quite useful, but much attention must be paid to the patient's oral uptake during the therapy, and the clinical effects should be evaluated in randomized control trials.     

Continuous infusion of chemotherapy on an outpatient basis via a totally implanted venous access port

170 patients were treated with continuous infusion of epirubicin, mitoxantrone, carboplatin or 5-fluorouracil through an implanted venous access port with a portable infusion pump. A total of 440 cycles were given on an outpatient basis. The patients were instructed how to dissolve their drugs and to change the syringes. The complication rate was low. 10 patients developed a thrombosis of the subclavian vein, resulting in cessation of therapy in 5. Pulmonary embolism occurred twice, in 1 patient during a period of subclavian vein thrombosis. Needle dislocation occurred 6 times and catheter occlusion 20 times. Patency was restored with saline or urokinase. Local infection occurred 3 times and systemic infection only once. This technique is suitable for continuous infusion of different cytostatic drugs on an outpatient basis. Patients were able to prepare their drugs at home and the system can remain in situ for 3 weeks without increasing the complication rate.     

Chemotherapy by ambulatory continuous infusion using a portable pump: a feasibility trial

43 metastatic cancer patients received 190 portable infusors over 24 hours or more. This portable infusor is a disposable material made by Travenol which operates without outside energy. The drug in an elastomere balloon reservoir is injected about 24 hours at a rate of 2 ml/hour. We used various drugs: CDDP, bleomycin, 5 fluorouracil, aracytine, velbe, voltarene. The patients were under hospital observation and received their treatment without any incident due to the pump itself. The patients who had already been perfused with the usual technique greatly appreciated the comfort of this light portable device. Our next step will permit us to estimate the use of these infusors by patients at home.     

Loco-regional chemotherapy at the outpatient clinic for gastric cancer patients with home enteral nutrition

In over the 10 years from 2000-2010, 21 gastric cancer patients received loco-regional chemotherapy with home enteral nutrition (HEN) at an outpatient clinic because of insufficient oral intake. These loco-regional chemotherapy regimens consisted of 5 intra-aortic chemotherapies, 4 hepato-arterial infusions and 12 intra-peritoneal chemotherapies. Five out of 8 cases that had measurable lesions showed PR, and 3 cases revealed PD. The patients received HEN with peptide central formula, 400-1,200 kcal/day in night time. The average duration of HEN was 12.9 months. The post-operative nutritional management was needed for continuation and securing of outpatient chemotherapy. The author reported an experience of the outpatient loco-regional chemotherapy with HEN for the gastric cancer patients who could not eat a sufficient volume of food.     

Outcomes of home anti-cancer chemotherapy--estimation of hepatic arterial infusion chemotherapy for patients with multiple liver metastases

A total of 18 patients (13: colon cancer, 5: gastric cancer) with multiple liver metastases (H3) underwent hepatic arterial infusion chemotherapy (HAI) using an implanted arterial port with portable syringe pumps in our outpatient clinic. Clinical perspective: overall response rate was 22.2% (CR: 1 case, PR: 3 cases (1 case: hepatectomy after HAI), NC: 12 cases, PD: 2 cases), however, 7 of 12 cases of NC were long NC (more than 6 months). No major complications with HAI were experienced. Patient Perspective: After HAI in our outpatient clinic, the 50% survival was 341 days, 50% hospital free days were 319 days and home stay rate was 92.9%. Societal Perspective: cost and hospital stay days were significantly reduced. Home anti-cancer chemotherapy using HAI for gastrointestinal cancer patients with multiple liver metastases was safe and efficient from the viewpoint of medical outcomes.     

The development of an outpatient treatment system for cancer chemotherapy

It is necessary to develop a system of treatment to provide cancer chemotherapy on an outpatient basis. Facilities needed include treatment service sites, outpatient laboratories, and chemotherapy pharmacies where safety cabinets are available. Medical oncologists, chemotherapy nurses and pharmacists should conduct cancer chemotherapy after obtaining informed consent from the patient. Chemotherapy protocols, ordering systems and risk management for medical errors must also be established in the agreement to perform chemotherapy. The problems encountered in the experiences at the Outpatient Treatment Service of National Cancer Center Hospital East are discussed.     

Hepatic arterial bolus chemotherapy for colorectal metastases using an implantable port

Twenty-one patients with isolated colorectal liver metastases underwent hepatic artery infusion (HAI) port implantation for regional chemotherapy with bolus injections of 5-FU, LV and fast drip of cisplatin. Ten of the 21 patients had previously failed systemic chemotherapy before HAI. Toxicity was moderate and no need for modulation of the chemotherapeutic dose was required. The objective response rate of the whole group was 52.4%. The patients, who had not previously received systemic chemotherapy, had a significantly higher response rate of 81.8% compared to patients treated previously by systemic chemotherapy, who had a response rate of 20% (p=0.0089). In addition, there was a difference in cumulative survival between these two groups. The HAI combined chemotherapy with 5-FU, LV and cisplatin given by bolus injection through an implantable port is effective therapy with similar response rate but considerable reduced toxicity compared to continuous HAI with FUdR. We assume that this therapy might prolong survival significantly especially in patients not treated before by systemic chemotherapy.     

Improved ambulatory syringe pump system for pain control therapy at home

Terumo Corporation has been developing products for use at home, such as the Cafty pump, based on the opionions and suggestions received through Home-Joint. This time we improved the ambulatory syringe pump TE-361 PCA, so that patients could use it at home. RESULTS: We had patients 49 to 78 years of age use it, continuously, at an injecting speed of 0.1 to 1 ml/h for 5 to 26 days. Patients requiring large volumes of a medicine were offered two or more pumps pre-filled with the medicine. Drug transportation problems were not reported, because of the doctor in charge transported the medicine constantly. Terumo call center did not receive any incidence of trouble, and no trouble was reported in the collected questionnaire. From these facts, it was suggested that this apparatus can be used safely for in-home medical treatment. CONCLUSION: The burden of expenses when two or more pumps are required and installation of the back-up equipment, etc. are problems that should be coped with separately. Moreover, a cooperation system is required in preparation for troubles. We want to establish a system that can be used with confidence by the patients.     

Intraarterial infusion chemotherapy for metastatic liver tumors using multiple anti-cancer agents suspended in a lipid contrast medium

An ethiodized oil, Lipiodol (Lipiodol Ultra-Fluid, Laboratoire Guerbet, Paris, France), when injected into the hepatic artery, is selectively retained by liver tumors. Thus, anti-cancer agents suspended in Lipiodol can be delivered specifically to liver tumors. Before clinical trials of this new drug delivery system were begun, the movements of drugs suspended in Lipiodol were examined in vitro. It was found that 5-fluorouracil, doxorubicin, and mitomycin C were continuously released from oil phase to water phase, and when these three drugs were collectively suspended in Lipiodol, each was released independently. During clinical investigations, 42 patients with unresectable metastatic liver tumors were treated with intraarterial infusions of anti-cancer drugs in Lipiodol. As a result, the administration of a combination of anti-cancer agents suspended in Lipiodol was shown to be effective in controlling metastatic liver tumors. It was concluded that such a method could be applied to a variety of metastatic liver tumors with different drug sensitivities.     

Intra-arterial infusion chemotherapy of hepatic carcinoma using a totally-implantable Infusaid pump

Three patients with primary carcinoma of the liver and 11 patients with metastatic carcinoma of the liver were treated by hepatic arterial infusion of 5-FU and Mitomycin C (MMC), using a totally-implantable, percutaneously-refillable infusion pump: INFUSAID 210, 400. The infusion cannulae were placed into the hepatic arteries under direct vision on laparotomy, and the pumps were placed in subcutaneous pockets. The implanted pumps were well tolerated in these patients, who received chemotherapy as outpatients; the only adverse effects noted were related to 5-FU and MMC toxicity. The cumulative duration of successful infusion exceeded 104 months (for individual patients: range 2 to 20 months; average 7.4 months). Complications associated with conventional intraarterial chemotherapy (artery thrombosis, catheter sepsis and dislodgement, pump infusion variation and pump failure) were not seen with the INFUSAID delivery system. The pump is refilled every two weeks via percutaneous puncture. All therapy was given on an outpatient basis. Pump acceptance and tolerance was 100%. Our study using this infusion pump to deliver 5-FU and MMC has shown response rates of 66% (2/3) for primary carcinoma of the liver with cirrhosis and 82% (9/11) for metastatic carcinoma of the liver. The average survival for the primary and metastatic carcinomas of the liver were 6.0 months and 8.4 months respectively. Utilization of the totally-implantable INFUSAID pump provides a convenient, cost-effective, and safe administration technique for patients with primary and metastatic carcinomas of the liver.     

Therapy for metastatic colorectal cancer with hepatic artery infusion chemotherapy using a subcutaneous implanted pump

Sixty-two patients with metastatic colorectal carcinoma involving the liver were treated by hepatic intra-arterial chemotherapy using an implantable infusion pump. The 53 patients with metastases confined to the liver had a median survival (MS) of 17 months and an objective response rate of 32%. Four patients (8%) demonstrated a complete response (CR), with normal abdominal computed tomography (CT) scan results and plasma carcinoembryonic antigen (CEA) levels, and 13 patients (25%) demonstrated a partial response (PR), with at least a 50% decrease in the liver lesions by CT scan and at least a 50% decrease in CEA levels. Thirty patients (57%) had stable disease (S), and six patients (11%) had no response (NR). Nine patients with extrahepatic tumor plus hepatic metastases had an MS of only 4.9 months. None of these patients had an objective response, and only four patients had S. Quality of response was clearly associated with longevity. Forty patients treated with floxuridine (FUDR) and mitomycin (M) (F + M) showed a 20% objective response rate, while the 13 patients treated with FUDR and dichloromethotrexate (DCMTX) (F + D) attained a 69% objective response rate. Although F + D treatment appears to be superior, there may have been selection biases that make such an observation only preliminary. Twenty-six (49%) of the 53 patients developed hepatitis during infusion chemotherapy, which resolved after temporary cessation of the chemotherapy. Of the 17 patients with CR or PR, 12 patients (71%) had hepatitis, whereas only 14 (39%) of the 36 patients with S or NR had hepatitis. Eleven patients had evidence of peptic ulceration by endoscopic examination during the infusion chemotherapy. All the ulcers healed after chemotherapy was discontinued.     

Single-agent and combination-drug regional chemotherapy for head and neck cancer using an implantable infusion pump

Chemotherapy delivered through angiographically placed catheters requires patient hospitalization, and is usually limited to short-term infusions. Treatment given through surgically placed catheters with external portable infusion pumps permits greater patient freedom and longer infusion durations. However, some patient restrictions remain, and thrombotic or infectious complications are common with long-term therapy. A totally implantable pump has allowed long-term intraarterial therapy in an outpatient population. Patient activity was unrestricted, and the complication rate has been low. This system has been used to deliver single-agent therapy with FUdR, dichloromethotrexate or bleomycin, and combination-drug treatment with cisplatin + FUdR or bleomycin + mitomycin C + dichloromethotrexate. The majority of patients have responded to at least one drug program. Seven of 14 patients who had pumps implanted over 1 year ago have received therapy for at least 1 year, and four patients have had functioning system for over 2 years. Systemic toxicity (except for nausea and vomiting with cisplatin) has been uncommon. Further clinical experience with these programs will be necessary to fully establish the objective response rate. However, the Infusaid Pump has proven safe, reliable and has high patient acceptance.     

Continuous venous infusion of vindesine in metastatic breast cancer: experience with a subcutaneously implanted system and portable pump

Fourteen patients with advanced pretreated breast cancer were treated with vindesine in continuous venous infusion (1.5 mg/sm/24 hours for 72 hours every 3 weeks). A totally implanted venous access and a portable pump were used. A total of 33 courses was administered. No objective response was observed and treatment was stopped. Drug-related toxicity consisted mainly of alopecia (64% of patients), nausea and vomiting (29%) and mucositis (29%). Catheter - related toxicity was observed in 6 patients (43%) and consisted of infection of the skin pocket in 4 patients and dislodging of the needle and catheter break in one patient. The feasibility of continuous venous infusion of vesicant drugs in outpatients is discussed.