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Clinical Study Of A New Ablative Agent: Chemotherapic Agents Lipiodol Emulsion

Posted on:2008-11-18Degree:DoctorType:Dissertation
Country:ChinaCandidate:Y ChenFull Text:PDF
GTID:1104360218961603Subject:Medical Imaging and Nuclear Medicine
Abstract/Summary:PDF Full Text Request
BackgroundPercutaneous ablation has become increasingly an important local therapy forthe treatment of tumors. The widely used procedures, radiofrequency ablation andpercutaneous ethanol injection, had reliable therapeutic effect for small tumors, butwere also limited by causing great pain and injury. In the present study, a kind of newablative agent, chemotherapic agents lipiodol emulsion (CALE), which can allowgreater concentration of chemotherapeutic agents and prolong the remaining timewithin tumors, was used to increase the ablative efficacy.PurposeTo investigate the method of percutaneous intratumoral CALE injection and toassess its effectiveness and safety for the treatment of primary liver cancer, othermalignant solid tumors and orbital venous malformations. Clinical significance wasevaluated.Patients and methodsThe present clinical study was divided into three groups:Group 1: Percutaneous intratumoral CALE injection for the treatment of primaryliver cancer. 57 patients were enrolled. Of these, 53 were male and 4 were female, with a mean age of 48.02 years (range, 19-70 years). 49 were diagnosed withhepatocellular carcinoma (HCC), 8 were cholangiocellular carcinoma. Of the 57study patients, eleven patients (19.3%) had a solitary lesion with a largest dimensionof<5 cm, 28 patients (49.1%) had a solitary lesion with a largest dimension of 5-10cm and 18 patients (31.6%) had a solitary with a largest dimension that exceeded 10cm. Ninety sessions of percutaneous CALE injection were performed. 90 target areasin all were treated. (Target area was defined as the area that planned to bepercutaneous injected with CALE).Group 2: Percutaneous intratumoral CALE injection for the treatment of someother malignancies. 25 patients were included in this group. These were patients withlung cancer (n=7), pulmonary metastasis from HCC (n=1), hepatic metastases fromcolon carcinoma (n=4), chromaffinoma (n=1), leiomyoma of stomach (n=1),dodecadactylon interstitialoma (n=1) after surgery, mediastinum metastase fromesophageal carcinoma (n=1), local recurrence of uterine cervix cancer (n=2) andovarian cancer (n=1) after surgery, metastatic tumors in the retroperitoneum lymphoidnode, chest wall, abdominal wall and pelvic cavity (n=5) from hepatic cancer (n=4) andbreast carcinoma (n=1), right adrenal metastatic tumor from lung cancer(n=1). 34target areas in all were treated. The size of the tumor ranged from 2.8-18 cm (mean,7.46 cm). Of the study patients, 6 (24%) had lesion that less than 3 cm, 4 (16%) had asolitary tumor with a largest dimension of 3-5 cm, 15 (60%) had a solitary lesion witha largest dimension that exceeded 5 cm. In all, 34 percutaneous CALE injectionprocedures were given to 34 target areas.All the patients in Group 1 and 2 underwent transcatheter arterialchemoembolization (TACE) or transcatheter arterial infusion (TAI) beforepercutaneous CALE injection.In these patients surgical operation were performed inthe 17 cases, including PLC (n=5), colon carcinoma (n=4), chromaffinoma (n=1), leiomyoma of stomach (n=1), dodecadactylon interstitialoma (n=1), esophagealcarcinoma (n=1), uterine cervix cancer (n=2), ovarian cancer (n=1) breast carcinoma(n=1), Preprocedural CT and digital subtraction angiography (DSA) were performedon all of the patients in group 1 and 2. The size, location, shape, boundary and bloodsupply of the lesions were observed and recorded. Of these lesions, all received lowor no blood supply. Percutaneous CALE injection was carried out under fluoroscopyor CT guidance. Therapeutic effect, side effect and complications were assessedbased on clinical manifestation, laboratory examination and fluoroscopy or CT oneweek after procedure. Follow-up was carried on in the post-procedural 1,3, 6 monthsand 1 year, and once six months thereafter. Local recurrences were treated underpatients' permission.Group 3: Percutaneous pingyangmycin lipiodol emulsion (PLE) injection for thetreatment of orbital venous malformations (OVMs). There were 15 cases (male 8,female 7; age range 8~14 years, mean 15 years) of left (n=9) or right OVMs (n=6).All patients had proptosis, and the proptosis was≤5mm in 11 cases, 5~8mm in 4cases, mean 4.2 mm. 4 patients noticed reduction in their vision and two had diplopia.These patients were examined by CT or MR, and injected with PLE after beingdiagnosed by direct intralesional venography. The efficacy and complications wereobserved during the following 8~42 months (mean, 23 months).Results(1) 90 sessions of percutaneous injection were successfully performed on 57patients with PLC, with 100% technique success rate. 40 sessions were performed onpatients with tumor less than 3 cm in greatest dimension, the volume of CALEinjected per session ranged from 3.0-7.0 ml (mean, 6.0ml). The number of CALEtreatment session on those whose tumor was 3-5cm in largest dimension was 43 and the volume of CALE injected per session ranged from 12.0-20 ml (mean, 15 ml). 7treatment sessions were performed on the patients who had lesion larger than 5 cm inlargest dimension. The amount of ablative agent per session ranged from 24-40 mlwith a mean 36 ml. The CALE diffused within the targeted areas in following ways:massive or patchy in 4 cases (4.4%), densely reticular in 79 (87.8%). diffusive downvessels in 2 (2.2%), granular in 5 (5.6%) and mixed diffusive in 8 (8.8%). Imagingfindings revealed that excellent therapeutic effect (defined as CALE deposited in100% of the target area) was achieved in 10 target areas (11.1%), good (defined asCALE deposited in more than 90% of the target area) in 47 (52.2%) and 33 (36.7%)target areas had response (defined as CALE deposited in less than 90% of the targetarea). Preprocedural serum AFP was positive in 43 patients and 75 sessions of CALEinjection were performed. The level of AFP decreased after receiving therapy.Excellent response (defined as serum APF value decreased by 50%) was achieved in17 patients (22.7%), good response (defined as serum APF value decreased by30%-50%) in 33 (44.0%) and 22 (29.3%) patients had response (defined as serumAPF value decreased by less than 30%). No response or even increased in 3 (4.0%).Serum AFP level in 14 patients (28%) decreased to normal after one session or moreof treatment. 54 lesions (60.%) were found with well distribution of thelipiodol-chemotherapy mixture on CT scan obtained 1 month after procedure.Follow-up ranged 2 months to six years (mean, 2.5 years). The median survival timewas 400d. The cumulative survival rates at 200d, 600d was 85% and 30%,respectively. Major adverse effects were as follows: fever (n=22, 24.4%), nausea andvomit (n=11, 12.2%), pain at the puncture site (n=17, 18.9%). Liver and renalfunction test levels and blood counts were within the normal range. No complicationswere observed during the period of follow-up.(2) 34 sessions of percutaneous injection were successfully performed on 25 patients with malignant solid tumors, with 100% technique success rate. The numberof CALE treatment session on those whose tumor was less than 3 cm in largestdimension was 6 and the volume of CALE per session ranged from 2.0-8.0 ml (mean,4.0 ml). 21 sessions were performed on patients with tumor 3-5 cm in greatestdimension, the volume of CALE injected per session ranged from 6.0-15 ml (mean,10 ml). 7 treatment sessions were performed on the patients who had larger than 5 cmin largest dimension. The amount of ablative agent injected per session ranged from18-35 ml with a mean 26 ml. The CALE diffused within the targeted areas infollowing ways: massive or patchy in 6 cases (17.6%), densely reticular in 27(79.4%), diffusive down vessels in 1 (2.9%), and granular in 4 (11.8%). Imagingfindings revealed that excellent therapeutic effect was achieved in 4 patients (11.8%),good in 13 patients (50%) and 11 patients (32.4%) had response. Measurements oftumor markers suggested excellent therapeutic response was achieved in 17 patients(22.7%), good in 33 patients (44.0%) and 22 patients (29.3%) had response. Noresponse or even increased in 4 patients (4.0%). Well distribution of thelipiodol-chemotherapy mixture was found in 12 lesions (35.3%). All patients werefollowed during 2 months to 4 years after treatment (mean, 1.6 years). The mediansurvival time was 400d. The cumulative survival rate at 200d was 90%. Majoradverse effects were as follows: 7 patients had fever (20.6%). 5 patients presentedwith nausea and vomit (14.7%). 7 patients reported pain at the puncture site. Liverand renal function test levels and blood counts were found to be normal.Complications happened to three patients, one with rectal fistula and relieved after 2months without specific treatment, one with pneumothorax and one withsubcutaneous pneumatosis, which absorpted spontaneously.(3) All the fifteen patients underwent technically successful injection with PLEunder fluoroscopy. The technique success rate was 100%. The volume of PLE injected per session ranged from 1.5-3.0 ml (mean, 2.2ml).All patients had partial orcomplete resolution of proptosis demonstrated by imaging detection, and showednormal ocular region appearance. Three had gained recovery of vision, and diplopiain two patients disappeared. Of the 19 patients, two with diffuse lesion presented lightproptosis (<2 mm) when placed at the head down position or under compression onthe vena cervicalis. Other complications, such as intraorbital hemorrhage, periorbitalscar were not observed during following-up periods.ConclusionsThe study suggests that percutaneous intralesional CALE injection is safe andeffective for the treatment of primary liver cancer and some other malignant solidtumors, and thus it can be applied to those patients as a less invasively method whoare not suitable treated transarterially. Intralesional injection with PLE for treatingOVMs is safe and effective, and can be spread used.
Keywords/Search Tags:primary liver cancer, radiofrequency ablation, transarterial embolization, orbit, antibiotics, anti-cancer, radiology, interventional
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