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PubMed1981

Disappearance of the predictive value of prognostic variables in childhood acute lymphoblastic leukemia: a report from Childrens Cancer Study Group.

The identification of important prognostic factors at diagnosis of childhood leukemia has been very useful in explaining the marked differences in disease outcome. After a complete remission is achieved, it is interesting to determine whether the ability to maintain a complete remission and the patient's survival continue to be influenced by the prognostic factors identified at diagnosis. If the maintenance of complete remission and survival continue to be influenced, it is important to determine the magnitude of this effect and its variations with time. Data from a study population of 936 children with newly diagnosed acute lymphoblastic leukemia were analyzed to determine the duration of effect for three variables showing strong prognostic influence: WBC, age at diagnosis, and sex. The strongest of these, WBC, showed a gradual attenuation of effect for children in progressively longer periods of complete continuous remission to a virtual disappearance at 24 months. Age and sex showed a similar reduction in prognostic effect with a negligible contribution at 15 months of continuous complete remission. However, sex becomes an important variables again with a late effect on recurrence results in patients who experience long periods of remission.

Adolescent↗

PubMed1982

A randomized prospective clinical trial of adjuvant C. parvum immunotherapy in 260 patients with clinically localized melanoma (Stage I): prognostic factors analysis and preliminary results of immunotherapy.

A total of 260 patients with clinically localized melanoma (Stage I) from 18 medical institutions in the Southeastern Cancer Study Group were randomized to receive either surgical treatment alone, or surgery plus Corynebacterium parvum immunotherapy. A multivariant analysis (Cox regression model) of nine prognostic factors was performed on 110 patients with a minimum of two years follow-up. The dominant prognostic variables were thickness (P = 0.0007) and anatomic location of the melanoma (trunk versus other, P = 0.015). Disease-free survival curves were then calculated for 204 surgically evaluable patients. Overall, there was no significant difference in three-year survival for the two-treatment arms, which was 81% for the adjuvant immunotherapy group compared to 67% for the surgical control group (P = 0.10). The median follow-up period was 24 months (range, 1-60 months). However, when the data was subgrouped by tumor thickness, an apparent benefit of immunotherapy was observed in 49 patients with melanomas greater than 3 mm in thickness. Only five of 23 such patients relapsed after receiving C. parvum. Their three-year disease-free survival was 73%. In contrast, 13 of 26 patients who did not receive immunotherapy have relapsed so far and their three-year disease-free survival was only 33% (P = 0.01). In the 175 patients with melanomas less than 3 mm in thickness, both treatment arms had identical three-year disease-free survival rates of 83%. No significant differences between the treatment arms were observed using other prognostic variables, including the level of invasion. Toxicity to C. parvum injections was minimal in most patients. It is concluded that a prognostic factor analysis is critically important in adjunctive trials of melanoma to determine which dominant variables should be used for analyzing patient subgroups; that C. parvum immunotherapy appears to be associated with an improved disease-free survival rate in the subgroup of patients with melanomas greater than 3 mm thickness (this early encouraging data must still be confirmed with continued patients accrual and a longer observation period); and that patients with melanomas less than 3 mm thickness have a relatively favorable prognosis after appropriate surgical treatment, and immunotherapy does not improve their survival rates.

Adolescent↗

PubMed1982

A prognostic factor analysis for use in development of predictive models for response in adult acute leukemia.

The pretreatment characteristics of 325 adults with acute leukemia who were treated at the M. D. Anderson Hospital between 1973 and 1977 have been evaluated to assess their value as prognostic indicators. The patient population includes all patients treated with an anthracycline (Adriamycin or rubidazone), cytosine arabinoside, vincristine, and prednisone during the time period. Most patients had one of the variants of acute myelogenous leukemia (75%), and the remaining patients had acute lymphoblastic leukemia (16%) or undifferentiated leukemia (8%). Twenty-one factors were found to be significantly associated with probability of obtaining a complete response. In addition to characteristics previously known to provide prognostic information such as age, temperature status at the start of treatment, morphology, the presence of Auer rods, sex, and hemoglobin level, we identified the presence of a documented antecedent hematologic disorder and the finding of insufficient metaphases on cytogenetic analysis using the squash technique as being major prognostic variables. In addition, the pretreatment biochemical characteristics of hypoalbuminemia and elevated blood urea nitrogen and creatinine were found to adversely influence prognosis. The prognostic significance of factors such as the leukocyte count and platelet count, identified in earlier studies, was not confirmed in this group of patients. From this natural-history analysis predictive models for response have been developed using multivariate logistic regression techniques. One of these models has been used to evaluate the effect of morphology, treatment, and cytogenetic pattern on response to the combination of drugs used.

Acute Disease↗

PubMed1985

Prognostic factors influencing relapse of squamous cell carcinoma of the maxillary sinus.

In 95 surgically staged patients with squamous cell carcinoma of the maxillary sinus, multivariate regression analyses were employed to identify prognostic factors. Possible prognostic factors for local control were TNM stage and type of surgical procedures: T2 or T3 tumors and use of total maxillectomy showed better local control rates (P less than 0.01). High radiation doses of 40 Gy or more also seemed to be of prognostic significance: P less than 0.2 for 40 to 60 Gy, and P less than 0.1 for 60 Gy or more. The risk of cervical relapse increased when the cheek or alveolus was grossly involved (P less than 0.2). However, since cervical relapse frequently accompanied uncontrollable primary recurrence or distant spread, and since cervical relapse alone was frequently salvaged by radical neck dissection, prophylactic irradiation to the neck is not recommended. Sex, age, nodal state, addition of chemotherapy, total doses of bleomycin or 5-fluorouracil (5-FU), or intra-arterial administration of chemotherapeutic agents did not appear to be of prognostic significance.

Adult↗

PubMed1985

The value of morphometry to classic prognosticators in breast cancer.

In 271 breast cancer patients with adequate follow-up for at least 5.5 and maximally 12 years, the value of morphometry to classic prognosticators of breast cancer (tumor size and axillary lymph node status) was assessed. Previous studies had indicated the value of this quantitative microscopic technique. Apart from quantitative microscopic features, subjective qualitative features such as nuclear and histologic grade were assessed as well. Univariate life-table analysis showed the significance (p less than 0.001) of several features such as lymph node status, tumor size, nuclear and histologic grade, and several morphometric variables (mitotic activity index, mean and standard deviation of nuclear area). Cellularity index was also significant (p = 0.02). Survival analysis with Cox's regression model, using a stepwise selection as well as backwards elimination, pointed to three features: mitotic activity index, tumor size, and lymph node status. Mitotic activity was the most important prognostic feature, but the combination of these three features in a multivariate prognostic index had even more prognostic significance. Kaplan-Meier curves showed that the 5-year survival of lymph node-negative patients (n = 146) is 85%, versus 93% in patients with a "good prognosis index" (n = 150). For lymph node-positive patients (n = 125), 5-year survival was 55%, compared with 47% in the "high index" (poor prognosis) patients (n = 121). Logistic discriminant analysis with 5.5-year follow-up as a fixed endpoint (191 survivors and 80 nonsurvivors) essentially gave the same results. Application of two instead of one decision threshold (e.g., numerical classification probability 0.60 and 0.40) decrease the number of false-negative and false-positive outcomes, however, with a number of patients falling in the class "uncertain." Thus, in agreement with other studies, morphometry significantly adds to the prognosis prediction of lymph node status and tumor size. Mitotic activity index is the best single predictor of the prognosis. An additional index advantage is that the multivariate model results in a continuous index variable that can be subdivided in many classes with an increasing risk of recurrence, so that more refined clinical therapeutic decision making is possible in individual patient care. The morphometric techniques are inexpensive and fairly simple and therefore can be applied in most pathology laboratories.

Actuarial Analysis↗

PubMed1986

Prognostic indicators of colon tumors. The Gastrointestinal Tumor Study Group experience.

This study sought to replicate and expand findings reported by the National Surgical Adjuvant Breast and Bowel Project (NSABP) on prognostic factors in resectable colon cancer. Mantel-Haenszel tests and the Cox model were used to analyze prognostic significance and effect of primary disease symptoms and tumor location in 572 patients from the Gastrointestinal Tumor Study Group (GITSG), with resected Dukes' B2 and C colon cancer. Tumor location (left, right, and rectosigmoid/sigmoid) was of low prognostic importance (P greater than 0.10), and did not effect survival or disease-free survival (P greater than 0.10). Obstruction was an important indicator of prognosis, independent of Dukes' stage (P = 0.03). Bowel perforation is associated with poor prognosis in disease-free survival (P = 0.001). Rectal bleeding had a positive impact on survival (P = 0.08). Thus, obstruction, perforation, and rectal bleeding (but not location) are found to be prognostic factors in patients with Dukes' B2 or C colon cancer.

Colonic Neoplasms↗

PubMed1986

Clinical and prognostic features of Philadelphia chromosome-negative chronic myelogenous leukemia.

Between 1965 and 1982, 105 patients with a diagnosis of Philadelphia chromosome-negative chronic myelogenous leukemia were referred to our institution with minimal or no prior therapy. The median age was 63 years and 64% were males. The overall median survival from time of referral was 14 months; 53% of patients survived 1 year and only 10% survived beyond 5 years. At the time of analysis, 92 patients (88%) were dead, 56% of deaths being preceded by a blastic crisis. Compared with Philadelphia chromosome-positive disease, patients with Philadelphia chromosome-negative chronic myelogenous leukemia were older and had a significantly higher incidence of anemia, thrombocytopenia, monocytosis, marrow blasts, decreased marrow megakaryocytes and a lower incidence of basophilia and thrombocytosis. Chromosomal abnormalities occurred in 33% of patients and consisted most frequently of trisomy 8, or an additional chromosome C, loss of the Y chromosome, or abnormalities in chromosomes #5 and #7. Of nine pretreatment characteristics significantly associated with poor survival, a multivariate analysis identified four to have independent additive prognostic significance: severe thrombocytopenia, hemoglobin levels less than 10 g/dl, increasing peripheral blasts and promyelocytes, and age 60 years or older. Monocytosis was not of prognostic significance. The derived prognostic model divided patients into three risk groups, low, intermediate, and high, with median survivals of 36, 16, and 3 months, respectively. The authors conclude that Philadelphia chromosome-negative chronic myelogenous leukemia is a distinct entity among the myeloproliferative syndromes with characteristic clinical and laboratory features and a poor prognosis. Prognostic factors and related risk categories were demonstrated within this disease entity.

Adolescent↗

PubMed1987

Prognostic factors in stage II endometrial carcinoma.

The rarity of Stage II endometrial carcinoma and variable treatment modalities have made the evaluation of prognostic factors difficult. Clinical, surgical, and pathologic characteristics were evaluated in 64 patients treated with whole pelvic irradiation and intracavitary radium followed by hysterectomy at The University of Texas M.D. Anderson Hospital and Tumor Institute from January 1965 to December 1983. Comparison of 5-year actuarial survival rates revealed the following statistically significant categories: age, grade, depth of myometrial invasion, disease extent at surgery including lymph node metastases, and pelvic cytology. Race, weight, and cell type were not significant prognostic factors. Evaluation of prognostic factors at surgery includes pelvic and para-aortic lymph node biopsies, omental biopsy, pelvic cytologic washings, and biopsy of any suspicious tissues. Patients with adverse prognostic factors are candidates for trials with adjuvant therapy.

Actuarial Analysis↗

PubMed1987

Myelodysplastic syndromes. A multiparametric study of prognostic factors in 336 patients.

Two groups of patients with a myelodysplastic syndrome (MDS) were analyzed by univariate (log-rank test) and multivariate (logistic regression) analyses to detect the most important prognostic factors. By stepwise analysis, the variables found to have prognostic significance for death were as follows: age, percentage of marrow blasts, presence of circulating blasts, and number of platelets. The variables found significant for predicting progression to acute leukemia (AL) were as follows: hemoglobin level, percentage of marrow blasts, and presence of circulating blasts. The first group of 193 patients was used to build a prognostic index which reflected the probability of a given patient dying or progressing to AL within 6, 9, or 12 months. The application of this prognostic index to a test group of 143 patients was used to determine the expected error rate and the validity of the prediction rule.

Age Factors↗

PubMed1988

Prognostic significance of DNA index, multiploidy, and S-phase fraction in ovarian cancer.

Paraffin-embedded tumor samples from 157 ovarian cancer patients were analyzed by DNA flow cytometry. Tumor ploidy had prognostic significance in both early and advanced ovarian cancer. After adjusting for stage, residual tumor mass, histopathologic type, treatment, and age of patient in a Cox regression analysis, the relative risk of death was two-fold higher in single DNA-aneuploid and sixfold higher in DNA-multiploid tumors as compared to DNA-diploid tumors (P less than 0.0001). A tetraploid DNA index was associated with a relatively low risk ratio, whereas hypertetraploid tumors were highly malignant. S-phase fraction (SPF) had prognostic value especially in DNA-diploid tumors. The simultaneous evaluation of DNA index, the number of aneuploid cell clones, and SPF gave more prognostic information than the determination of tumor ploidy alone. On the basis of these parameters we have developed a classification of tumor DNA histograms for better prognostic assessment of ovarian cancer.

Aged↗

PubMed1988

DNA flow cytometry and prognostic factors in 1331 frozen breast cancer specimens.

Breast cancer proliferative capacity as determined by the DNA thymidine labeling index, along with estrogen and progesterone receptor status, is highly predictive for risk of relapse and overall survival. Recently, DNA ploidy and proliferative capacity (S-phase fraction [SPF]) as determined by flow cytometry have also shown significant prognostic value. The authors have developed a technique which allows a 50 to 100 mg aliquot of the same frozen breast tumor specimen routinely employed in steroid receptor assays, to be assayed for both DNA ploidy and SPF by flow cytometry. Of the 1331 tumors examined, DNA histograms were evaluable for ploidy in 89% (1184) of specimens examined; 57% of these were aneuploid. Adapting a trapezoidal model to estimate SPF in both diploid and aneuploid tumors, the authors found 81% (1084) to be evaluable for SPF, with a median SPF of 5.8% for the entire population. The median SPF was significantly lower in diploid tumors (2.6%) than in aneuploid tumors (10.3%, P less than 0.0001). Both aneuploidy and high SPF were strongly associated with absence of steroid receptors. Aneuploid tumors showed more striking differences in the frequency of high S-phase values with respect to receptor status and age or menopausal status, whereas diploid but not aneuploid tumors showed lower SPF in node-negative versus node-positive patients. Because it is particularly important to identify the high-risk minority of node-negative patients, the authors examined the node-negative group separately. High SPF subgroups appeared in each category of receptor status and age or menopausal status within the node-negative group, suggesting that SPF will be an independent prognostic factor. With the DNA flow cytometric methods used here, it is now practical to determine ploidy and SPF for nearly every breast cancer patient. These factors, which show associations with established prognostic factors, such as receptor status can now be fully evaluated for their prognostic significance in broad patient populations.

Aneuploidy↗

PubMed1988

Prognostic factors in neuroblastoma. Clinical, histopathologic, and immunohistochemical features and DNA ploidy in relation to prognosis.

Tumor samples from 58 patients diagnosed and treated for neuroblastoma or ganglioneuroblastoma in a single institution from 1967 to 1981 were included in a study of prognostic factors. Histopathology, certain immunohistochemical markers, and DNA ploidy were evaluated along with clinical variables such as tumor stage, primary site, and patient's age at diagnosis. Children under 1.5 years of age at diagnosis had a much better prognosis than did older ones, and this variable was the best prognostic indicator. Tumor Stages I to II and IVS, primary tumor site above the diaphragm, and tumor differentiation were also related to a better prognosis. The Shimada classification was of no additional prognostic value in our study. Neither was the immunohistochemical marker pattern, but it was sometimes helpful in establishing the tumor diagnosis. Tumor-cell ploidy, however, seemed to afford additional prognostic information because the 11 patients with aneuploid tumors under the age of 1.5 years at diagnosis all survived in contrast to only five of nine patients with diploid tumors in the same age group. It is possible that this was due to a better response to treatment in the aneuploid group. Our results suggest that patients with diploid neuroblastomas of undifferentiated histology and those over the age of 1.5 years at diagnosis might be selected for more intense treatment.

Adolescent↗

PubMed1988

Prognostic factors in head and neck melanoma. Effect of lesion location.

Cutaneous malignant melanomas of the head and neck are prognostically engimatic. In addition to known prognostic determinants of stage and lesion microstage, lesion location also appears to have prognostic importance. The authors have reviewed a series of 83 microstaged head and neck melanoma patients in order to analyze the relative importance of these factors. There were 36 males and 47 females with a median age of 56 years. Eighty-one percent had pathologic Stage I disease, 7% were Stage II, and 12% were Stage III. The primary location was face in 32 patients, neck in 18, ear in 12, and scalp in 21 patients. The actuarial 5-year survival according to lesion thickness was 86% for melanoma less than 1.0 mm, 56% for 1 to 2 mm thick lesions, 47% for 2.1 to 4 mm thick lesions, and 25% for melanomas greater than 4.0 mm. The 5-year survival according to lesion location was 78% for facial and 58% for neck melanomas; for ear and scalp, the respective survivals were 33% and 37%. Median thickness was 2.0 mm for facial and 1.85 mm for neck lesions. It was 2.7 mm for ear and 2.0 mm for scalp lesions (differences not significant). There were no microstage factors that correlated with the adverse prognosis seen with scalp and ear melanomas. Multivariate analysis in the entire series (all clinical stages) showed the following to be significant: stage, thickness, and location of the primary melanoma (all less than 0.0002). In clinical Stage I melanoma, the significant prognostic factors were location (P = 0.035), thickness (P = 0.008), level (P = 0.024), and ulceration (P = 0.035). The prognosis of head and neck melanoma is uniquely influenced by location of the primary lesions in addition to stage, thickness, level, and ulceration, as observed with other cutaneous melanomas at other sites. Ear and scalp melanomas are high-risk lesions whose poor prognosis is not readily explained by any of the microstage factors reviewed.

Adolescent↗

PubMed1988

Multivariate analysis for histologic prognostic factors in soft tissue sarcomas.

To investigate histologic prognostic factors in soft tissue sarcomas (STS), multivariate analysis was performed on 236 patients with complete clinical information. These included 141 males and 95 females with an age range from 1 to 85 years (median, 47.6 years). Histologically, malignant fibrous histiocytoma (33.5%) was the most common type followed by synovial sarcoma (11%), liposarcoma (10%), rhabdomyosarcoma (7%), and leiomyosarcoma (7%). Monofactorial analysis revealed that sex, depth, location, histologic grade, cellularity, frequency of mitosis, and necrosis were significant prognostic factors. By multivariate analysis, only frequency of mitosis and depth of tumors were proved to be of prognostic significance. The prognostic importance of the frequency of mitosis as shown in previous and the present studies indicates that further investigation of the cell proliferation in patients with STS is required.

Age Factors↗

PubMed1988

Improving the prognostic value of DNA flow cytometry in breast cancer by combining DNA index and S-phase fraction. A proposed classification of DNA histograms in breast cancer.

To optimize the prognostic value of DNA flow cytometry in breast cancer the authors calculated several parameters from the DNA histogram, including the DNA index, the size and number of aneuploid peaks as well as S-phase and G2/M-phase cell cycle fractions. Of these, DNA index and S-phase fraction (SPF) proved to be the most valuable prognostic indices. DNA aneuploidy was associated with a three-fold risk of death as compared to DNA diploidy (P less than 0.0001). The highest risk of death was associated with hypertetraploid (greater than 2.20) DNA index, whereas a tetraploid DNA index (1.80-2.20) was associated with a relatively low risk. The SPF had significant additional prognostic value in both DNA diploid (P = 0.0002) and DNA aneuploid (P = 0.02) tumors. By combining DNA index and SPF the authors defined three types of DNA histograms, which were associated with favorable, intermediate, and poor prognosis of the patients. DNA diploidy together with low (less than 7%) SPF (type I DNA histogram) was associated with very favorable prognosis, whereas DNA aneuploidy with high DNA index (greater than 2.20) or high (greater than 12%) SPF (type III DNA histogram) was related to the worst prognosis with approximately eight-fold relative risk of death. In a Cox multivariate regression analysis the type of DNA histogram was an independent and most powerful prognostic indicator in breast cancer. The other independent factors in the Cox analysis were primary tumor size, nodal status, and progesterone receptor status.

Aged↗

PubMed1988

Prognostic value of estrogen and progesterone receptors in operable breast cancer. Results of a univariate and multivariate analysis.

From October 1977 to December 1983, estrogen receptor (ER) and progesterone receptor (PR) levels were measured in 645 tumors from women with primary, unilateral, nonmetastatic breast cancer. All of them were treated surgically. Some received adjuvant radiotherapy, adjuvant chemotherapy, or adjuvant hormonotherapy. A level of greater than 5 fmol/mg cytosolic protein was considered as positive for both ER and PR. Unifactorial analysis, using Kaplan and Meier estimates and the log-rank test, revealed that disease-free survival (DFS) and overall survival (SV) were both strongly related to age, tumor size, nodal status, nodal effraction, histopathologic grading (SBR), ER, and PR. Menopausal status and number of intramammary tumor foci were not significant. Multifactorial analysis, using Cox's model, revealed a strong relationship between SV and age (poor prognosis [pp]: less than or equal to 37 years old), menopausal status (pp: postmenopausal) tumor size, nodal status (pp: N+ greater than 3), nodal effraction, ER (pp: less than or equal to 5 fmol/mg), histopathologic grading (pp: SBR = 3), and PR (pp: less than or equal to 5 fmol/mg). Similarly, multifactorial analysis revealed a strong correlation between DFS and age, tumor size, nodal status, nodal effraction, histopathologic grading, and PR. A prognostic score taking into account these prognostic factors was calculated for DFS and SV. Analysis of this score allowed us to divide our patients into four significantly different (P less than 0.0001) groups with high, intermediate, and low risk of relapse. Our procedure was then validated using the sample test technique. These results show that both ER and PR have their own prognostic weight and should be considered, among other classic prognostic factors, when adjuvant therapies are indicated after surgical treatment of breast cancer.

Adult↗

PubMed1989

Prognostic value of quantitative pathologic features and DNA content in individual patients with stage I endometrial adenocarcinoma.

The prognostic value of clinical features, qualitative and quantitative pathologic characteristics and steroid receptor incidence was evaluated in 50 patients with Stage I endometrial adenocarcinoma. It turned out that many of these features were prognostically important. Estrogen receptor content was not significantly associated with prognosis in our material, but patients with progesterone receptor positive lesions had a better survival than those in which the tumors were progesterone receptor negative. Multivariate analysis also clarified that only three features in combination had independent significance: mean shortest nuclear axis, DNA index, and depth of myometrial invasion (in sequence of decreasing importance). The prognostic rule consisting of these features overshadowed the value of all other features investigated. The overriding prognostic value of this highly reproducible rule was clear from the complete separation of 27 survivors and six nonsurvivors in the learning set of 33 patients. In an independent test set, all three nonsurvivors and 13 of the 14 survivors were correctly classified, thus confirming the accuracy and reliability of the developed rule to predict the outcome of future patients with Stage I endometrial adenocarcinoma.

Adenocarcinoma↗

PubMed1990

Flow cytometric analysis of the DNA content of non-small cell lung cancer. Ploidy as a significant prognostic indicator in squamous cell carcinoma of the lung.

To assess the prognostic value of DNA ploidy in non-small cell lung cancer (NSCLC), we performed a flow cytometric study using paraffin-embedded archival material from 158 patients who underwent surgical resection between 1980 and 1982. Single-variable histograms were examined and the results of these histograms were correlated with clinicopathologic characteristics and outcome. Histograms that could be analyzed were obtained in 146 cases, of which 85 (58%) were aneuploid and 61 (42%) were diploid. Survival analysis showed that patients with diploid squamous cell carcinomas (SCC) survived significantly longer than those with aneuploid SCC (a 5-year survival rate of 70% as compared with 26% [P = 0.002], respectively), and the results were independent of stage. However, DNA ploidy was not a significant prognostic factor in non-SCC (P = 0.337). Ploidy did not correlate with other clinicopathologic variables such as stage, nodal status, degree of differentiation, nuclear grade, and mitotic rate. These results suggest that DNA ploidy, as determined by flow cytometric analysis, provides an independent prognostic variable for patients with SCC and that it should be considered in treatment planning. However, non-SCC of lung may have different biologic variables, and their prognostic variables should be evaluated separately.

Adenocarcinoma↗