Three-year Actuarial Survival Research Articles

Symptomatic improvement after transmyocardial laser revascularization: how long does it last?

Background. The aim of this study was to determine whether short-term clinical improvement after isolated transmyocardial holmium laser revascularization (TMLR) in patients with coronary artery disease not amenable to traditional treatment is maintained through a longer follow-up. Methods. Between November 1995 and June 1999 34 patients underwent TMLR (mean age, 67 ± 7 years); previous revascularization procedures had been performed in 76%. Preoperatively, mean angina class was 3.6 ± 0.5 in 12 patients with unstable angina; mean left ventricular ejection fraction was 47% ± 9%. Results. There was 1 early death due to low cardiac output. Mean duration of TMLR and of the entire operation was 25 ± 12 minutes and 125 ± 43 minutes, respectively. There were no major postoperative complications; mean hospital stay was 8 ± 4 days. There were 8 late deaths caused by stroke (2 patients), cardiac failure (1 patient), and myocardial infarction (5 patients). Follow-up of current survivors ranges from 4 to 48 months (mean, 32 ± 12 months). At 1-year follow-up mean angina class was 1.8 ± 0.8; but at a later follow-up (mean, 35 ± 10 months) it significantly increased to 2.2 ± 0.7 ( p = 0.005). Three-year actuarial survival was 76% ± 8% and freedom from cardiac events 44% ± 10%. Conclusions. Our results show that after initial clinical improvement many patients experience return of angina or cardiac events; this questions the long-term symptomatic benefit of TMLR.

Extensive surgery after high-dose preoperative chemoradiotherapy for locally advanced recurrent rectal cancer.

This was a pilot study of high-dose preoperative concurrent radiation and chemotherapy before extensive surgery in patients with locally advanced recurrent rectal cancer. Here we report on curative resectability, acute toxicities during chemoradiotherapy, surgical complications, local control, and three-year survival rates achieved with this aggressive multimodal regimen. Between 1994 and 1997, 35 previously nonirradiated patients with pelvic recurrence of rectal cancer were entered in the study. All patients presented with tumor contiguous or adherent to adjacent pelvic organs and were not deemed amenable to primary curative surgery. A total radiation dose of 50.4 Gy with a small-volume boost of 5.4 to 9 Gy was delivered in conventional fractionation (single dose, 1.8 Gy). 5-Fluorouracil was scheduled as a continuous infusion of 1,000 mg/m2/day on Days 1 to 5 and 29 to 33. Six weeks after completion of chemoradiotherapy, patients were reassessed for resectability, and radical surgery was attempted whenever feasible. After preoperative chemoradiotherapy 28 of 35 patients (80 percent) underwent resection with curative intent. In 16 of 35 patients (57 percent) extended resection of adjacent organs was performed. Resections with negative margins were achieved in 17 patients (61 percent); 9 patients had microscopic, and 2 patients had gross residual disease. There was no postoperative mortality. Fourteen patients (44 percent) experienced postoperative complications. Toxicity from chemoradiotherapy occurred mainly as diarrhea (National Cancer Institute Common Toxicity Criteria Grade 3; 23 percent), dermatitis (Grade 3; 11 percent), and leucopenia (Grade 3; 11 percent). One patient died of tumortoxic multiple organ failure during chemoradiotherapy. With a median follow-up of 27 months, local re-recurrence after curative resection was observed in only three patients (18 percent); six patients developed distant metastases. Three-year actuarial survival rate was significantly improved after complete resection (82 percent) as compared with noncurative surgery (38 percent; P = 0.03). A combination of high-dose preoperative chemoradiotherapy followed by extended surgery can achieve clear resection margins in more than 60 percent of patients with recurrent rectal tumor not amenable to primary surgery. An encouraging trend evolved for this multimodal treatment to improve long-term local control and survival rate.

Sphincter preservation of leiomyosarcoma of the rectum and anus with local excision and brachytherapy.

The aim of this study was to determine the outcome of patients with leiomyosarcoma of the rectum or anus treated with local excision and brachytherapy. Eight patients with leiomyosarcoma of the rectum (7 patients) or anus (1 patient) were treated with a transanal excision followed by a temporary iridium-192 interstitial implant to 4,500 cGy. Median tumor size was 4.2 (range, 1.5-5) cm. Margins were positive in six patients, negative in one patient, and close in one patient. With a median follow-up of 53 months, median survival time was 53 months and the three-year actuarial survival rate was 71 percent. The cumulative incidence of failure as a component of failure for local was 25 percent (2/8), for abdominal was 0 percent (0/8), and for distant was 25 percent (2/8). Four patients eligible for functional analysis all had excellent sphincter function (1-2 bowel movements per day, no soilage). In selected patients the use of conservative surgery followed by brachytherapy is a reasonable alternative to an abdominoperineal resection. However, more experience and longer follow-up are needed before this approach can be recommended routinely.

Intraductal neoplasms of the pancreas

Since 1980 a group of pancreatic tumors have been termed intraductal papillary mucinous tumors (IPMT). Because these tumors occupy an intraductal position they are demonstrated by pancreatography to reside in the main pancreatic duct (MPD) or side branch ducts (SBD). Lesions of IPMT result in abdominal pain or pancreatitis symptoms because mucin production or papillary growth results in ductal obstruction. Only 104 cases had been reported in the literature by 1996 but more are being presented in abstract form. We reviewed our own 33 cases to assist defining operative decision-making criteria. All cases of IPMT between 1989 and 1997 were reviewed for clinical presentation, anatomy by endoscopic retrograde cholangiopancreatography and computed tomography, histologic findings, and long-term outcomes. Our cases were older (65 years) and presented with disease centered mainly in the head of the gland. Clinical presentation was epigastric pain (82%), pancreatitis (56%), weight loss (36%), diabetes (27%), and jaundice (9%). Operations were pancreatectomy in 31 (Whipple n = 15, total n = 5, distal n = 10, local n = 1), bypass only (n = 1), and no operation (n = 1). Malignancy was found in 14 of 33 (42%). Factors significantly associated (P <0.05 Fisher exact test) with malignancy were history of alcohol abuse or death from disease. Jaundice or presence in both MPD and SBD approached a significant association with malignancy but not abdominal pain, weight loss, diabetes, preoperative serum elevations of amylase, SGOT, CA-19-9, or CEA; diffuse MPD dilation, gland region, gross mucus in ducts or filling defects, cytology, calcifications, or a pancreatic mass. In 31 resected patients after a follow-up of 37 months (1 to 103) death had occurred in 6 of 13 malignant cases and 0 of 18 with benign disease. Three-year actuarial survival was 82% (all) and 56% (malignant). Symptom recurrence after resection was found in 6 of 31 at a mean of 13 months postoperatively and was associated with death from disease (P <0.05) or presence of pain preoperatively. Malignancy is common with IPMT and is more likely to be present with the clinical history of alcohol abuse or jaundice and if the tumor involves both the MPD and the SBD. The prognosis after resection is better than pancreatic cancer but the 19% recurrence of symptoms was equally seen with benign or malignant cases owing to residual disease in pancreatic remnants. The amount of resection should be extensive in patients likely to have malignancy (alcohol, jaundice, MPD+SBD). In those likely to redevelop symptoms, ie, those with preoperative pain, a careful assessment should be made via imaging studies for extent of disease.

Local Recurrence of Carcinoma of the Tongue after Glossectomy: Patient Prognosis

We conducted a retrospective review of the prognosis for patients with local recurrence after surgical treatment of carcinoma of the tongue. Glossectomy for squamous cell carcinoma of the tongue was performed in 167 patients. Local recurrence developed in 32 patients including 21 with local recurrence alone, 10 with locoregional recurrence and one with locodistant recurrence. The incidence of local recurrence increased with tumor stage (from 16% of T1 tumors to 46% of T4 carcinomas). Eleven (34%) patients underwent surgical salvage for local recurrence, with only one (9%) patient surviving free of carcinoma at 43 months post-surgical salvage. All of the remaining 21 patients with local recurrence were treated palliatively and all died within one year. Patients who underwent surgical salvage had significantly higher survival rates compared to those treated palliatively. Close follow-up after glossectomy is important for early detection of local recurrence amenable to surgical salvage. However, the overall prognosis for patients with local recurrence was poor, with a three-year actuarial survival rate of only 3%. Therefore, prevention of local recurrence with adequate initial surgical treatment is essential.

Long-term results of total lymphoid irradiation in the treatment of cardiac allograft rejection

To evaluate the short and long-term effects of total lymphoid irradiation (TLI) in the treatment of cardiac transplant rejection. Between 1986 and 1995, 48 courses of TLI were delivered to 47 cardiac transplant patients. In 37 patients, TLI was administered for intractable allograft rejection despite conventional therapy while 10 patients received TLI prophylactically. The prescribed radiation dose was 8 Gy in 0.8 Gy fractions twice weekly to mantle and inverted-Y plus spleen fields. Postirradiation follow-up ranged from 6 months to 9.1 years, with a mean of 3.1 years. The actual mean dose was 7.3 Gy delivered over a mean of 39 days. Fifty-six percent of patients required treatment delay or abbreviation because of thrombocytopenia, leukopenia, infection, or unrelated problems. In patients treated for intractable rejection, rejection rates dropped from 0.46 to 0.14 and to 0.06 episodes/patient/month before, during, and after TLI (p < 0.0001). Rejection rates continued to drop throughout follow-up. Prednisone requirements decreased from 0.41 mg/kg before treatment to 0.21 mg/kg afterward (p < 0.0001). The ratio of helper to cytotoxic-suppressor T-cells decreased during TLI from 1.33 to 0.89, and remained low at 0.44, 2-4 months after treatment. Infection rates were not increased and two patients developed malignancy. Rejection rates were high during prophylactic treatment and this protocol was abandoned. Three-year actuarial survival after irradiation was 60% for patients with intractable rejection and 70% for the prophylactic cohort. TLI is an effective treatment for control of intractable cardiac rejection. Episodes of rejection and steroid dosage requirements are decreased for up to 9.1 years. A possible mechanism of action is long term alteration in T-lymphocyte subsets. Patients experience transient bone marrow suppression but no increase in infection or bleeding. Long-term complications of TLI are not appreciably different than conventional immunosuppression.

Radiotherapy with high dose rate brachytherapy boost and concomitant chemotherapy for stages IIB and III esophageal carcinoma: Results of a pilot study

Radiotherapy (RT) and concomitant chemotherapy (CT) is the standard treatment for non resectable esophageal cancer. Usual total radiation dose is 50 Gy. In order to enhance local control rate a Phase II study was initiated to evaluate the feasibility of a combined treatment with an external radiation dose of 60 Gy and three cycles of concomitant CT, using the three main active drugs (CDDP, 5 FU and MMC), followed by a high dose rate (HDR) brachytherapy delivering 10 Gy. Fifty-three patients, 48 men and 5 women, were entered in this study. Stages were evaluated with CT scan and with endoscopic sonography. Fifteen were Stage IIB, 38 Stage III. Treatment consisted of conventional fractionated RT to a total dose of 60 Gy delivered with 2 Gy per fraction, one fraction per day and five fractions per week. The CT regimen was a combination of Cisplatinum (CDDP) 20 mg/m2 and 5 Fluorouracil (5FU) 600 mg/m2 continuous infusion, from days 1-4 Mitomycin C (MMC) was given at 6 mg/m2 on day 1. Three cycles were administered on days 1, 22, and 43. Brachytherapy was delivered one week after the end of external radiation therapy. Full radiation therapy dose was delivered for 94% of the patients. CT compliance, evaluated on the mean relative dose-intensity was 85% for CDDP, 81% for 5FU and 51% for MMC. Overall grade 3 and 4 WHO toxicity rates were 23% and 7%, respectively. Haematologic toxicity was the most limiting factor. One patient died from treatment toxicity. Local control rate at one year was 74%. Three-year actuarial survival rate was 27%. Distant metastasis was the main cause of treatment failure. Swallowing score was good for 75% of the patients. Stage, performance status and weight loss were prognostic factors. This regimen with high dose RT, HDR brachytherapy and concomitant CT is feasible; however, a high level of haematologic toxicity was observed with the CDDP, 5FU and MMC regimen. Despite a poor compliance with CT, treatment results are very encouraging for patients with locally advanced disease.

Preliminary results of preoperative 5-fluorouracil, low-dose leucovorin, and concurrent radiation therapy for clinically resectable T3 rectal cancer.

We report the downstaging, sphincter preservation, acute toxicity, and preliminary local control and survival results of preoperative 5-fluorouracil (5-FU), low-dose leucovorin (LV), and concurrent radiation therapy followed by postoperative LV/5-FU for treatment of patients with clinically resectable T3 rectal cancer. A total of 32 patients received two monthly cycles of preoperative LV/5-FU (bolus daily X 5). Radiation therapy (5,040 cGy) began concurrently on day 1. Postoperatively, patients received a median of two monthly cycles of LV/5-FU (range, 0-10). The complete response rate was 9 percent pathologic and 13 percent clinical, for a total of 22 percent. Total Grade 3+ acute toxicity during the preoperative combined modality segment was 25 percent (8/32). Of the 20 patients who were thought to initially require an abdominoperineal resection and for whom the intent of treatment was sphincter preservation, 17 (85 percent) were able to undergo sphincter-preserving surgery. With a median follow-up of 22 (3-59) months, none have developed local failure, and the three-year actuarial disease-free survival rate was 60 percent. Our data reveal encouraging downstaging, sphincter preservation and acute toxicity with this regimen. Additional follow-up is needed to assess the long-term local control and survival rates.

Does Resection of Adrenal Metastases From Non-Small Cell Lung Cancer Improve Survival?

Background. Metastatic non-small cell lung cancer (NSCLC) carries a dismal prognosis, which is minimally affected by chemotherapy. Solitary brain metastases from NSCLC have been resected with 5-year survivals of 10% to 30%. The objective of this study was to determine if resection of isolated adrenal metastases improves survival. Methods. Isolated adrenal metastases were found in 14 patients with NSCLC. Eight patients had resection after cis-platinum-based chemotherapy, and 6 received chemotherapy alone. Results. Median survival in the surgical group was significantly greater than that in the chemotherapy group (31 versus 8.5 months; p = 0.03). All patients in the chemotherapy group were dead by 22 months. Three-year actuarial survival in the surgical group was 38%. No difference in locoregional stage, size of adrenal metastases, patient age, or performance status was present between the two groups. Conclusions. Long-term disease-free survival is possible after resection of isolated adrenal metastases from NSCLC. Resection of isolated adrenal metastases should be considered if the primary NSCLC is resectable.

551 High dose radiotherapy (RT), concomitant chemotherapy (CT) and high dose rate brachytherapy for non resectable esophageal cancer

RT and concomitant CT is the standard treatment for non resectable esophageal cancer. Usual total radiation dose is 50Gy. In order to enhance local control rate a phase II study was initiated to evaluate the feasibility of a combined treatment with an external radiation dose of 60Gy and 3 cycles of concomitant CT followed by a high dose rate brachytherapy delivering 10Gy (2 applications with 7 days interval). 73 patients (pts), 28 men and 5 women were treated between 1989 and 1993. Stages were evaluated with CT scan and with endoscope sonography for 41 pts: 13 were Stage IIB, 50 Stage III and 10 Stage IV. Treatment consisted in a conventional fractionated RT to a total dose of 60Gy delivered with 2Gy per fraction, one fraction per day and 5 fractions a week. The CT regimen was a combination of Cisplatinum 25mg/m² dl to d4, 5 Fluorouracil 600mg/m² continuous infusion dl to d4. 3 cycles were administered on dl, d22 and d43. Brachytherapy was delivered one week after the end of external radiation therapy. Full radiation therapy dose was delivered for 96% of the patients. CT compliance, evaluated on the drug dose and the CT interval, was good for 77% of the patients. Overall grade 3 and 4 WHO toxicity rates were 23% and 7% respectively. One pt died from treatment toxicity. Local control rate at one year was 74%. Three-year actuarial survival rate was 27%. Distant metastase was the main cause of treatment failure. Predictive factors of late effects related to brachytherapy and evaluation of a swallowing score will be presented, In a multivariate analysis Stage was the only prognostic factor. In conclusion this regimen with high dose RT and 3 cycles of concomitant CT is feasible. Treatment results are very encouraging for pts with locally advanced disease.

Excellent Technique Survival on Home Peritoneal Dialysis: Results of a Regional Program

To examine peritoneal dialysis technique survival in our regional, continuous ambulatory peritoneal dialysis (CAPD) program. Retrospective analysis. Tertiary care dialysis program at an academic medical center. 155 patients representing all those in the peritoneal dialysis program between October 1, 1987 and October 1, 1990. The study analyzed patient and technique survival as well as the reasons for discontinuation of dialysis. In addition, the incidence and type of peritonitis and exit-site infection were also analyzed. Three-year actuarial patient survival was 66% and three-year technique survival was 86%, with data censored for death and transplant patients. Fifty-seven percent of transfers to hemodialysis were due to peritonitis, usually fungal or multiorganism bacterial. Only 1 patient failed due to exit-site and tunnel infection, and 1 due to inadequate dialysis. The catheter removal rate was 0.04 per patient-year. Excellent CAPD technique survival can be achieved if exit-site and tunnel infection rates are low.

Combined modality treatment using BID radiation for locally advanced non-small cell lung carcinoma

From February 1988 to August 1991, 82 patients were treated on Phase II trial of split-course multimodality treatment for locally advanced, non-small cell lung cancer (NSCLC). Treatment consisted of twice-daily radiation (150 cGy/fraction) delivered with concomitant infusional cisplatin, etoposide, and fluorouracil for 1 week every third week. Patients were classified before initial treatment as either potentially resectable (eligible for surgery [ES]) or ineligible for surgery (IES). The ES group consisted of 38 Stage IIIA and 7 Stage IIIB patients. The IES group had 5 patients staged as IIIA and 32 staged as IIIB. Most patients were staged clinically. ES patients received three cycles of treatment (39 Gy) before resection. IES patients received four cycles (60 Gy) delivered with curative intent. Thirty-nine of 45 ES patients underwent resection. The pathologic response rate was 27%. Three-year actuarial local control was 86% for 41 evaluable ES patients. Three-year actuarial survival for the whole ES group was 39%, with a median follow-up for living patients of 32 months. The IES group faired less well, with an 18% 3-year actuarial survival. Treatment was well tolerated with a median weight loss of one-half pound, mild or moderate pneumonitis in 5%, mild esophagitis in 15%, and severe nausea and/or vomiting in 10% of patients. Treatment-related mortality was 5%. Patients treated with conventional radiation alone for Stage III NSCLC are rarely cured. This well tolerated Phase II study demonstrated encouraging results for such patients. Both local control and survival appeared promising, especially in patients rendered resectable after combined-modality treatment.

Adjuvant Chemotherapy for Invasive Urothelial Cancer: Experience with a Methotrexate, Vincristin, Cisplatin, Cyclophosphamide, Adriamycin and Bleomycin (MVP-CAB) Regimen: A Preliminary Report

MVP-CAB chemotherapy (methotrexate, vincristine, cisplatin, cyclophosphamide, adriamycin and bleomycin) was administered to 28 patients with high grade, locally-invasive or regional lymph node-involved urothelial cancer as an adjuvant therapy after radical surgery. The median follow-up period of all the evaluated patients was 24 (range, 5-62) months. The median disease-free durations in patients with pT1b+2+3 bladder and upper urothelial cancer were 26 and 22 months, respectively. In contrast, all patients with pT4 disease or lymph node metastases had a recurrence within 24 months of surgery. The median disease-free durations in patients with pure transitional cell carcinoma (grade 3) of the bladder and upper urothelial cancer were 19 and 18 months, respectively. The median disease-free duration in patients with grade 3 pT1b+2+3 pure transitional cell carcinoma was 19 months. In contrast, the median disease-free duration in bladder cancer patients with pT1b+2+3 squamous cell carcinoma components was 35 months. The three-year actuarial survival rates were 79 and 89% for pT1b+2+3 bladder and upper urothelial cancer, respectively, while the three-year actuarial survival rates of patients with pT4 bladder cancer and pT4 upper urothelial cancer were 0 and 100%, respectively. The two-year actuarial survivals in the bladder cancer and upper urothelial cancer patients with lymph node involvement were 0 and 100%, respectively. The three-year actuarial survivals of patients with pure transitional cell carcinoma (grade 3) were 53 and 80% in bladder cancer and upper urothelial cancer patients, respectively. The three-year actuarial survival rate in patients with squamous cell carcinoma or adenocarcinoma components which did not recur was, however, 100%. Although randomized studies comparing MVP-CAB and M-VAC (methotrexate, vinblastin, adriamycin and cisplatin) or other chemotherapeutic regimens will be necessary, we believe our results indicate that MVP-CAB chemotherapy may be useful as an adjuvant therapy for patients with urothelial cancer, including those with squamous cell carcinoma and adenocarcinoma components. More intensive MVP-CAB chemotherapy, i.e., increasing the dose of cisplatin and giving at least five courses, as well as the use of granulocyte colony stimulating factor and a new antiemetic drug (granisetron), will, however, be necessary for patients with pT4 or lymph node-involved disease.

Ewing sarcoma of the pelvis. Clinicopathological features and treatment.

The results of treatment in twenty-seven patients who had a Ewing sarcoma of the pelvis were reviewed. Six patients had had metastatic disease at the time of the diagnosis. The three-year actuarial survival of these patients was 17 per cent (95 per cent confidence interval, 8 to 52 per cent). Of the twenty-one remaining patients, thirteen had received chemotherapy and radiation therapy to the primary lesion and eight had had chemotherapy and operative resection, with or without radiation therapy. The actuarial five-year over-all survival was 25 per cent (95 per cent confidence interval, 6 to 51 per cent) in the group that had had radiation without a resection and 75 per cent (95 per cent confidence interval, 31 to 93 per cent) in the group that had had a resection (p < 0.005, log-rank method). The actuarial over-all five-year survival was 45 per cent (23 to 65 per cent) for all patients who had had localized disease when first seen. Actuarial local failure analysis (the censoring of patients who died without evidence of local failure before the two-year follow-up examination) revealed a rate of local failure of 44 per cent (14 to 79 per cent) in the group that had been treated with chemotherapy and radiation alone compared with 13 per cent (0 to 53 per cent) in the patients who had had a resection, but this difference was not significant (p > 0.25, log-rank method).(ABSTRACT TRUNCATED AT 250 WORDS)

A single-center experience of renal transplantation in thirteen Jehovah's Witnesses.

The beneficial effects of pretransplant blood transfusions on the success rate of renal transplantation have been so overwhelmingly emphasized that there is virtually no information on the fate of grafts in nontransfused patients transplanted during the last decade. Since 1979, all patients who have undergone renal transplantation at the University of Minnesota have routinely received random blood transfusions except Jehovah's Witnesses. Jehovah's Witnesses refuse transfusions but will accept renal allografts. From 1979 to May 30, 1987, primary renal allografts were placed in thirteen nontransfused Jehovah's Witnesses; six patients received kidneys from mismatched living-related donors, two patients received HLA-identical sibling grafts, and five patients received cadaveric renal allografts. The range of follow-up of the thirteen patients was 3-93 months, with a mean of 45 months and a median of 50 months. The outcomes after renal transplantation in Jehovah's Witnesses were compared with those of a paired control group (n = 25) matched for age, date of transplant, donor source, and diabetic status. The overall three-year actuarial patient and graft survival rates of the Jehovah's Witnesses were 83 per cent and 66 per cent, versus 80 per cent and 77 per cent for the controls. Although the outcomes after renal transplantation in Jehovah's Witnesses were similar to those of the control group, the Jehovah's Witnesses had an increased susceptibility to rejection episodes. The cumulative percentage of incidence of primary rejection episodes was 77 per cent at three months in the Jehovah's Witnesses versus 44 per cent at 21 months in the matched control group. The consequence of early allograft dysfunction from rejection was particularly detrimental to Jehovah's Witnesses who developed severe anemia (hemoglobin (Hgb)* 4.5 g per cent)-two early deaths occurred in the subgroup with this combination of problems. The overall results suggest that renal transplantation can be safely and efficaciously applied to most Jehovah's Witnesses but those with anemia who undergo early rejection episodes are a high-risk group relative to other transplant patients.

Limited stage small cell lung cancer: analysis of clinical prognostic factors.

In an attempt to identify clinical features of prognostic value in patients with limited stage small cell lung cancer, we retrospectively reviewed the records and chest roentgenograms of 101 such patients seen at Vanderbilt University Hospital. All patients were treated with combination chemotherapy regimens of comparable efficacy with or without chest radiotherapy and/or surgical resection. Median survival for the 101 patients was 16 months; the three-year actuarial survival was 14%. Elevated serum LDH level at the time of diagnosis was predictive of improved survival by both univariate and multivariate analyses (P less than .01). Initial tumor volume (calculated from tumor measurements) on chest roentgenogram and clinical TNM stage were unrelated to survival. Until the prognostic significance of an elevated serum LDH level is confirmed by other investigators, we cannot recommend any modification in the current system for staging small cell lung cancer. Although patients with limited stage small cell lung cancer form a clinically heterogeneous group, they should continue to be treated uniformly.

Bone Marrow Transplantation for Leukemia Following a New Busulfan and Cyclophosphamide Regimen

Abstract Busulfan 16 mg/kg and cyclophosphamide 120 mg/kg were used as conditioning prior to allogeneic marrow transplantation in 50 adult patients with acute nonlymphocytic leukemia (ANLL), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML). A standard risk group of 20 patients included those with acute leukemia in remission and CML in chronic phase. A high-risk group of 30 patients included individuals with refractory acute leukemia, acute leukemia in relapse, acute leukemia following preleukemia, and CML in accelerated and blastic phase. Complete remission and sustained complete engraftment were achieved in all evaluable patients. The duration of aplasia was remarkably short (median of 8 days), resulting in a low infection rate during the period of neutropenia, a reduced need for blood product support, and a short length of hospital stay. Three-year actuarial relapse-free survival in both standard-risk (88.9% +/- 10.5%) and high- risk (50.5% +/- 9.6%) groups compares favorably with that reported with total body irradiation (TBI) containing regimens.

Bone marrow transplantation for leukemia following a new busulfan and cyclophosphamide regimen

Busulfan 16 mg/kg and cyclophosphamide 120 mg/kg were used as conditioning prior to allogeneic marrow transplantation in 50 adult patients with acute nonlymphocytic leukemia (ANLL), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML). A standard risk group of 20 patients included those with acute leukemia in remission and CML in chronic phase. A high-risk group of 30 patients included individuals with refractory acute leukemia, acute leukemia in relapse, acute leukemia following preleukemia, and CML in accelerated and blastic phase. Complete remission and sustained complete engraftment were achieved in all evaluable patients. The duration of aplasia was remarkably short (median of 8 days), resulting in a low infection rate during the period of neutropenia, a reduced need for blood product support, and a short length of hospital stay. Three-year actuarial relapse-free survival in both standard-risk (88.9% +/- 10.5%) and high-risk (50.5% +/- 9.6%) groups compares favorably with that reported with total body irradiation (TBI) containing regimens.

Hepatic resection in 125 patients.

Hepatic resection was performed in 125 patients. Ninety-three of the 125 patients had malignant neoplasms; primary liver carcinoma in 61, metastatic liver carcinoma in 15, carcinoma of the bifurcation of the hepatic ducts in 16, and carcinoma of the gallbladder in one. Performance of hepatic resection was complicated by the presence of liver cirrhosis and jaundice in 42 and 19 patients, respectively. Nine of the 125 patients died within 30 days of the operations, with an operative mortality of 7.2%. Eight of the nine deaths were due to liver failure in the cirrhotic patients who underwent resection of more than two segments of the liver. None of the jaundiced patients died postoperatively. The three-year actuarial survival rates of the patients with hepatocellular carcinoma, metastatic liver carcinoma, and carcinoma of the bifurcation of the hepatic ducts were 31%, 56%, and 21% respectively.

Survival in End‐stage Diabetic Renal Disease

The results of renal transplantation in patients with diabetes mellitus were studied in 100 consecutive patients transplanted between Dec. 1972 and June 1982. The study period was divided into two parts, 1972-76 (era I, 21 patients, 18 with juvenile onset diabetes) and 1977-82 (era II, 79 patients, 72 with juvenile onset diabetes). A group of 168 non-diabetic patients, aged 20-54 years, receiving primary grafts during the same period served as controls to the 72 juvenile onset diabetics from era II. The three-year actuarial patient survival of transplanted diabetics improved from 48% during era I to 76% during era II and was then not significantly inferior to that of the non-diabetic controls. The three-year actuarial graft survival rate was significantly higher for recipients of kidneys from living related donors than for those who had received kidneys from cadaveric donors (CD) among both diabetic and non-diabetic patients. However, the three-year graft survival rate was significantly higher (56%) for non-diabetic than diabetic CD recipients (37%). The overall survival in diabetes mellitus was strongly influenced by the outcome of retransplantation during era II (12 patients). Thus, 69 patients were alive, 64 with a functioning graft, at the end of the observation period.