Seven year follow-up data were available on 36 of 40 breast carcinoma patients in whom breast tissue ferritin concentrations at the time of surgery were known. 18 patients were alive and free of recurrence or second tumor (Group 1) and 11 died with breast cancer (Group 2). Patients with lower tissue ferritin concentrations defined as less than 319 ng/mcp (nanograms of ferritin/milligram of cytosol protein) were at reduced risk: 86% of patients with low tissue ferritin concentration survived free of recurrence or second tumor vs. 40% of patients with high tissue ferritin concentration (P = 0.0056). Mean breast carcinoma tissue ferritin concentration was 295 +/- 52 ng/mcp in Group 1 and 444 +/- 55 ng/mcp in Group 2 (P = 0.036). Lymph node involvement was predictive of mortality from breast carcinoma (P = 0.0003), but did not correlate with mean tissue ferritin concentration (P = 0.082). 10/10 (100%) patients who had both low tissue ferritin concentration and absence of lymph node involvement were in Group 1. The correlation of breast tissue ferritin concentration with histopathologic dedifferentiation and with prognosis suggests tumor tissue ferritin as a marker of malignant potential.
Tumor tissue samples from 25 patients with adenocarcinoma of the colon, twelve related samples of normal colons as well as five serum specimens from the same patients were analyzed for ferritin. The average ferritin content of the tumor tissue was 788 ng/mcp with a range of 47-1,745 ng/mcp. The average ferritin content of normal colon mucosa was 115 ng/mcp with a range of 32-230 ng/mcp. Two specimens of metastatic colon cancer taken from the retroperitoneal space and liver, respectively, contained 3,867 and 2,827 ng/mcp of ferritin. The ferritin content of the tumor tissue was higher than that of the normal colon in 8 of 9 patients who had specimens obtained from both sites. The amount of ferritin found in tumor tissue was independent of sex, age, and the site of the original tumor. This study shows that the ferritin content of colon neoplasms is elevated and indicates that the tumor tissue may be the direct source of elevated serum levels of ferritin previously observed in cancer patients.
Ten-year results are presented of 124 patients with malignancy apparently limited to the distribution of the hepatic artery, treated to prospective protocol with continuous infusion of 5-FUdR through an hepatic artery catheter. Nearly all patients had moderate to massive hepatic replacement. Of 88 patients with colorectal carcinoma, 64 (73%) had clinically objective and subjective remission. Median survival for responders was 13 months; for the entire group, ten months. Of 13 patients with hepatoma, nine had clinically significant regression with a median survival of 11 months. Ten patients had carcinoma of the gall bladder or bile duct with seven obtaining clinically significant regression. Complications encountered are discussed and are similar to other series. Of the patients experiencing clinically significant remission, all but one reached the complete independence performance status, and 84% reached normal activity levels. Thus, for hepatic localized tumor, this therapy is worthwhile and practical.
In women with local/regional breast cancer autotransplants were rated: 1) appropriate in those with > or = 10 cancer-involved lymph nodes; 2) uncertain in those with 4-9 cancer-involved nodes; and 3) inappropriate in women with < or = 3 cancer-involved lymph nodes. In women with metastatic breast cancer autotransplants were rated: 1) appropriate in those with metastases to 'favorable' sites (skin, lymph node, pleura) and a complete or partial response to chemotherapy; 2) uncertain in women with metastases to 'unfavorable' sites (lung, liver, or central nervous system) and a complete response to chemotherapy or those with bone metastases and a complete or partial response or stable disease after chemotherapy; and 3) inappropriate in other settings.
The Southwest Oncology Group in a prospective randomized study compared one year of adjuvant combination chemotherapy with continuous CMFVP to two years of intermittent L‐PAM in women with operable breast cancer with histologically positive axillary lymph nodes. In fully evaluable patients with a 42‐month median and 30‐month minimum follow‐up, treatment failures have occurred in 26% of 145 receiving CMFVP and 47% of 167 women given L‐PAM (P = 0.002). Disease‐free survival times were significantly longer with CMFVP than with L‐PAM in the following subgroups: premenopausal women (P = 0.002), postmenopausal women (P = 0.002), women with 1–3 involved axillary nodes (P = 0.003), and women with four or more involved axillary nodes (P = 0.002). CMFVP was effective in pre‐ and postmenopausal women. There is a significant difference in survival in favor of CMFVP compared to L‐PAM (P = 0.005). The life table estimates of survival at 42 months are 86% for women on the CMFVP treatment arm and 73% for women on the L‐PAM treatment arm. There was no correlation between the interval from mastectomy to onset of chemotherapy (between one and six weeks) and recurrence rates. Acute toxicity with both treatment arms was moderate and reversible. These results show that continuous CMFVP is superior to intermittent L‐PAM in decreasing recurrences and increasing survival in both pre‐ and postmenopausal women with operable breast cancer with histologically involved axillary nodes.
Over a 24‐month period, the Southwest Oncology Group (SWOG) conducted a randomized prospective chemotherapeutic trial in 158 patients with advanced prostatic cancer. Patients were initially randomized to receive either a combination of Adriamycin and cyclophosphamide (AC) or a single agent, hydroxyurea (H), and then crossed over to the other treatment on failure. Of the 137 evaluable patients, 43 (31%) had classically measurable metastatic disease in the lymph nodes, skin, chest, or liver. Focusing their efforts on this subset of patients with measurable disease, the authors of this report found the combination AC to have a superior response rate to the single agent, hydroxyurea. Objective response to AC was seen in 6 of 19 (32%) and in only one of 24 (4%) patients randomized to hydroxyurea (P = 0.06, Fisher's exact test). However, in the larger group of 137 evaluable patients, a survival advantage was not seen for those individuals treated with AC. Failure to demonstrate a survival advantage for an objectively superior drug combination would suggest the need for more active phase II agents in this disease.
Combination chemotherapy has been used in the treatment of acute leukemia, malignant lymphoma, and, more recently, solid tumors. This study was designed to randomize between combination 5-fluorouracil (5-FU),, cyclophosphamide, and vincristine sulfate, vs. sequential use of these drugs in patients with breast carcinoma. Forty-six patients received 5-FU 7.5 mg/kg, cyclophosphamide 4 mg/kg daily for 5 days, and vincristine sulfate 0.015 mg/kg on days 1 and 8, repeated monthly. Thirty patients received a single drug in full dose (5-FU 15 mg/kg, cyclophosphamide 8 mg/kg daily for 5 days in monthly course, or vincristine sulfate .02 mg/kg weekly). The design was such that if the patient's tumor failed to respond to the single agent, the subsequent drug was used. I n the combination group, 20 (43.5%) had objective responses. The mean survival of the combination group was 8.6 months. Sixteen of the 30 patients (53.3%) receiving sequential therapy responded to one or more of the three drugs, Mean survival of this group was 10.2 months. Evaluation of the drug toxicity between sequential vs. combined therapy revealed three drug related deaths in the patients treated with 5-fluorouracil alone, with one death in the combination-treated group. Statistical analysis showed no significant difference in tumor response or patient survival between patients treated with these three drugs used in sequence or in combination.
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